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U.S. Department of Health and Human Services

Product Classification

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Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMCW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type 510(k)
Regulation Number 870.4875
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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