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U.S. Department of Health and Human Services

Product Classification
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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRD
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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