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FDA 510(k), K063785, SPIDERFX EMBOLIC PROTECTION DEVICE
FDA 510(k), K063785, SPIDERFX EMBOLIC PROTECTION DEVICE
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510(K) Number: K063785
Device Name: SPIDERFX EMBOLIC PROTECTION DEVICE
Manufacturer: EV3 INC
Device Classification Name: temporary coronary saphenous vein bypass graft for embolic protection
Regulation Number: 870.1250
Classification Product Code: NFA
Date Received: 12/21/2006
Decision Date: 01/19/2007
Regulation Medical Specialty: Cardiovascular
Device Name: SPIDERFX EMBOLIC PROTECTION DEVICE
Manufacturer: EV3 INC
Device Classification Name: temporary coronary saphenous vein bypass graft for embolic protection
Regulation Number: 870.1250
Classification Product Code: NFA
Date Received: 12/21/2006
Decision Date: 01/19/2007
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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