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U.S. Department of Health and Human Services

Product Classification

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Device catheter, embolectomy
Regulation Description Embolectomy catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXE
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Intervention 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
Accredited Persons
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