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U.S. Department of Health and Human Services

Product Classification
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Device temporary coronary saphenous vein bypass graft for embolic protection
Regulation Description Percutaneous catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNFA
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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