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U.S. Department of Health and Human Services

Product Classification

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Device catheters, transluminal coronary angioplasty, percutaneous
Regulation Description Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLOX
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Intervention Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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