FDA 510(k), K091641, HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
FDA 510(k), K091641, HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
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510(K) Number: K091641
Device Name: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
Manufacturer:
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 06/04/2009
Decision Date: 06/30/2009
Regulation Medical Specialty: Neurology
Device Name: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
Manufacturer:
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 06/04/2009
Decision Date: 06/30/2009
Regulation Medical Specialty: Neurology