ULTRASCORE™ Focused Force PTA Balloon 7mm x 20mm, 130cm catheter

ULTRASCORE™ Focused Force PTA Balloon 7mm x 20mm, 130cm catheter
ULTRASCORE - US3513072

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.

No Data Available

• Shaft Length, 130 Centimeter
• Balloon Diameter, 7 Millimeter
• Balloon Length, 20 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00801741116933

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