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U.S. Department of Health and Human Services

Product Classification

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Device introducer, catheter
Regulation Description Catheter introducer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDYB
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.1340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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