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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 Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 870.1290
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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