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U.S. Department of Health and Human Services

Product Classification
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Device device for open surgical explant of endovascular prostheses
Definition This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
Physical State non-implantable, mechanical, surgical tool
Technical Method device mechanically releases the fixation features of the endovascular prosthesis and removes it from the vessel
Target Area central or peripheral vein or artery where endovascular prostheses are implanted
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeSHR
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4520
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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