.035

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EverCross - AB35W03150135

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.

• Outer Diameter: 3 Millimeter
• Length: 150 Millimeter
• Catheter Gauge: 5 French
• Working Length,135,CM;Compatible Guidewire,0.035,IN;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00821684039625

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