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U.S. Department of Health and Human Services

Product Classification

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Device catheter, percutaneous, cutting/scoring
Definition To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
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.
Technical Method 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.
Target Area Peripheral arteries and arteriovenous dialysis fistulae
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePNO
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible