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U.S. Department of Health and Human Services

Product Classification
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Device percutaneous catheter, ultrasound
Regulation Description Percutaneous catheter.
Definition Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Physical State Catheters that deliver electro-mechanical energy to a blood vessel via a catheter which is connected via a cable to a generator.
Technical Method Delivered through the peripheral arterial system. Use of shockwave to disrupt plaque or blood clot.
Target Area Peripheral Vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePPN
Premarket Review Office of 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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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