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U.S. Department of Health and Human Services

Product Classification

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Device dilator, vessel, surgical
Regulation Description Surgical vessel dilator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.4475
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
Accredited Persons