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U.S. Department of Health and Human Services

Product Classification
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Device coronary mechanical thrombectomy with aspiration
Regulation Description Embolectomy catheter.
Definition To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Physical State Coronary Catheter
Technical Method Remove thrombus from coronary vasculature
Target Area Coronary vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQEX
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.5150
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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