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U.S. Department of Health and Human Services

Product Classification

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Device vessel guard or cover
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.
Physical State a 2-dimensional material
Technical Method The material is cut to size, then laid over a blood vessel and sutured/tacked into nearby tissue to keep it from migrating
Target Area over a blood vessel, typically the aorta during anterior vertebral surgery
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOMR
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible