FDA 510(k), K100454, HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
FDA 510(k), K100454, HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
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510(K) Number: K100454
Device Name: HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, neurovascular embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 02/17/2010
Decision Date: 04/22/2010
Regulation Medical Specialty: Neurology
Device Name: HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, neurovascular embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 02/17/2010
Decision Date: 04/22/2010
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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