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U.S. Department of Health and Human Services

Product Classification

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Device vessel guard or cover, to facilitate revision surgeries
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMFX
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.3470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible