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U.S. Department of Health and Human Services

Product Classification

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Device stylet, catheter
Regulation Description Catheter stylet.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRB
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type 510(k)
Regulation Number 870.1380
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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