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U.S. Department of Health and Human Services

Product Classification

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Device catheter, angioplasty, peripheral, transluminal, dual-balloon
Regulation Description Percutaneous catheter.
Definition Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Physical State Comprised of a catheter body with two concentric distal inflatable balloons.
Technical Method Used independently for dilation or dilatation of diseased peripheral vasculature to restore blood flow
Target Area Peripheral vasculature exclusive of coronary arteries.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNVM
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
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
Third Party Review
Accredited Persons