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U.S. Department of Health and Human Services

Product Classification

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Device system, catheter or guidewire, steerable (magnetic)
Regulation Description Steerable catheter control system.
Regulation Medical Specialty Cardiovascular
Review Panel Neurology
Product CodeNDQ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
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 Not Third Party Eligible
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