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U.S. Department of Health and Human Services

Product Classification

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Device system, catheter control, steerable
Regulation Description Steerable catheter control system.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXX
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type 510(k)
Regulation Number 870.1290
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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