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U.S. Department of Health and Human Services

Product Classification

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Device catheter, percutaneous, neurovasculature
Regulation Description Percutaneous catheter.
Definition To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Physical State Percutaneous catheter for neurovasculature
Technical Method Uses a catheter to provide access to the neurovasculature for interventional or diagnostic procedures
Target Area Neurovasculature
Regulation Medical Specialty Cardiovascular
Review Panel Neurology
Product CodeQJP
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 870.1250
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
Accredited Persons
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