- Physicians Office Resource

VascuTrak® PTA Dilatation Catheter 5 mm x 100 mm, 80 cm catheter
VascuTrak® - V1850100S

Device Description

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Balloon diameter, 5.0 Millimeters

Catheter Shaft Length, 80 Centimeters

Balloon Length, 100 Millimeters

Balloon diameter, 5.0 Millimeters
Catheter Shaft Length, 80 Centimeters
Balloon Length, 100 Millimeters

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PNO

Device Name: Catheter, Percutaneous, Cutting/Scoring

Device Class: 2

Physical State: Cutting/scoring catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon. The cutting/scoring elements are usually metal.

Definition: To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is typically placed using a guidewire and guiding catheter. The active end is typically expanded and the cutting/scoring surfaces are apposed to the vessel wall to cause cracking or breaking of the stenosis.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral arteries and arteriovenous dialysis fistulae

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00801741062117

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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