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U.S. Department of Health and Human Services

Product Classification

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Device catheter, intravascular occluding
Regulation Description Intravascular occluding catheter.
Definition Call for PMAs to be filed by 12/26/96 (61 FR 50708 (9/27/96))
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHBZ
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type PMA
Regulation Number 882.5150
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible