Manufacturer > Cook Medical > Devices > Advance® 14LP Low-Profile PTA Balloon Dilatation Catheter

Advance® 14LP Low-Profile PTA Balloon Dilatation Catheter

Device-Type

PTA Ballons

Targated Speciality

Vascular

Manufacturer

Cook Medical


The Advance 14LP Low Profile PTA Balloon Dilatation Catheter is a single-to- double-lumen catheter with a balloon near its distal tip. The proximal part of the catheter consists of one lumen, attached to a luer lock. The distal part of the catheter consists of two independent lumens. Of these two, the proximal lumen extends the length of the catheter and is used to expand the balloon; the distal lumen extends from the catheter tip to a point approximately 50 cm proximal to the balloon and is used for placement of wire guides. Inscribed on the strain relief of the proximal fitting are the balloon diameter (mm) and the balloon length (mm).

The balloon is manufactured from an extra-thinwall, high-strength, minimally- compliant material. Particular care should be taken in handling the balloon to prevent damage. It will inflate to the indicated size parameters when utilizing proper pressure recommendations. Adhere to balloon inflation pressure parameters indicated in the Compliance Card insert. Refer to label for further information. Use of a pressure gauge is recommended to monitor inflation pressures.

The balloon surface has a hydrophilic coating which becomes slippery when in contact with fluids. Platinum/iridium radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.36 mm) wire guides.

Safety informations

INTENDED USE

The Advance 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.


CONTRAINDICATIONS

None known


WARNINGS

• Do not exceed rated burst pressure.1 Rupture of balloon may occur. Adhere to balloon inflation pressure parameters in the Compliance Card insert.

Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall. Use of a pressure gauge is recommended to monitor inflation pressures.

• Do not use a power injector for balloon inflation. Rupture may occur.

Burst pressure data were analyzed using factors for a one-sided tolerance to determine with 95% confidence that 99.9% of these balloons would not burst at or below the calculated rated burst pressure.


PRECAUTIONS

• This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

• The Advance 14LP Low Profile PTA Balloon Dilatation Catheter has been designed for introduction into the vascular system utilizing percutaneous (Seldinger) technique. Alternatively, an introducer sheath may be used. Refer to label information for the appropriate introducer sheath size.

• The balloon is constructed of a heat-sensitive material. Do not heat or attempt to shape the catheter tip.

• In heavily scarred access sites, use of an introducer sheath is recommended.

• Manipulate the catheter using fluoroscopic control.

• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.

• Use the catheter prior to the expiration date specified on the package.

• The catheter is not intended for the delivery of stents.

• All stents should be deployed in accordance with the manufacturer’s indications and instructions for use.

Potential adverse events

• Air embolism

• Aneurysm

• Arrhythmias

• Arteriovenous fistula

• Death

• Drug reactions, allergic reaction to contrast medium

• Hemorrhage or hematoma

• Hypo/hypertension

• Infection and pain at insertion site

Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model Accepts Wire Guide Diameter inch Catheter Length Inflated Balloon Diameter mm Balloon Length cm Compatible Sheath Fr Rated Burst Pressure atm
Advance 14LP Low Profile PTA Balloon Catheter
G50313 .014 170 cm 2 2 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50314 .014 170 cm 2 4 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50315 .014 170 cm 2 6 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50316 .014 170 cm 2 8 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50317 .014 170 cm 2 12 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50318 .014 170 cm 2 16 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50319 .014 170 cm 2 20 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50320 .014 170 cm 2.5 2 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50321 .014 170 cm 2.5 4 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50322 .014 170 cm 2.5 6 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50323 .014 170 cm 2.5 8 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50324 .014 170 cm 2.5 12 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50325 .014 170 cm 2.5 16 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50326 .014 170 cm 2.5 20 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50327 .014 170 cm 3 2 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50328 .014 170 cm 3 4 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50329 .014 170 cm 3 6 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50330 .014 170 cm 3 8 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50331 .014 170 cm 3 12 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50332 .014 170 cm 3 16 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50333 .014 170 cm 3 20 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50334 .014 170 cm 4 2 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50335 .014 170 cm 4 4 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50336 .014 170 cm 4 6 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50337 .014 170 cm 4 8 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50338 .014 170 cm 4 12 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50339 .014 170 cm 4 16 4.0 16
Advance 14LP Low Profile PTA Balloon Catheter
G50340 .014 170 cm 4 20 4.0 16
  • Model : G50313
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50314
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50315
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50316
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 8
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50317
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 12
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50318
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 16
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50319
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2
  • Balloon Length cm : 20
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50320
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50321
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50322
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50323
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 8
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50324
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 12
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50325
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 16
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50326
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 2.5
  • Balloon Length cm : 20
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50327
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50328
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50329
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50330
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 8
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50331
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 12
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50332
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 16
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50333
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 3
  • Balloon Length cm : 20
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50334
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50335
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50336
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50337
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 8
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50338
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 12
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50339
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 16
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16
  • Model : G50340
  • Procedure : -
  • Accepts Wire Guide Diameter inch : .014
  • Catheter Length : 170 cm
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 20
  • Compatible Sheath Fr : 4.0
  • Rated Burst Pressure atm : 16

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