PTA A35HPV05020135 FORTREX V01
Fortrex™ - A35HPV05020135
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
- Keep away from sunlight
- Keep dry
- The Fortrex catheter should be stored in cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Device Sizes
- Outer Diameter: 5.0 Millimeter
- Length: 135.0 Centimeter
- Max. Guidewire .89 mm
- Catheter Gauge: 6.0 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LIT
Device Name: Catheter, Angioplasty, Peripheral, Transluminal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1250
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00821684057315
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