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U.S. Department of Health and Human Services

Product Classification

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Device marker, cardiopulmonary bypass (vein marker)
Regulation Description Vascular graft prosthesis.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMAB
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3450
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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