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FDA 510(k), K133626, AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
FDA 510(k), K133626, AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
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510(K) Number: K133626
Device Name: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 11/26/2013
Decision Date: 12/20/2013
Regulation Medical Specialty: Cardiovascular
Device Name: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 11/26/2013
Decision Date: 12/20/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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