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U.S. Department of Health and Human Services

Product Classification
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Device embolization agent, vascular
Definition For occluding peripheral vessels
Physical State Injectable material(s) that forms (e.g., polymerizes, precipitates) in situ to obstruct blood flow. It is unlike the coil or particulate embolization devices in that it polymerizes in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.
Technical Method Material(s) delivered via catheter to the peripheral vessel to occlude the vessel and obstruct blood flow
Target Area Peripheral vessels
Review Panel Cardiovascular
Product CodeQVG
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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