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FDA 510(k), K052523, PROXIS SYSTEM
FDA 510(k), K052523, PROXIS SYSTEM
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510(K) Number: K052523
Device Name: PROXIS SYSTEM
Manufacturer: VELOCIMED INC.
Device Classification Name: temporary coronary saphenous vein bypass graft for embolic protection
Regulation Number: 870.1250
Classification Product Code: NFA
Date Received: 09/14/2005
Decision Date: 09/07/2006
Regulation Medical Specialty: Cardiovascular
Device Name: PROXIS SYSTEM
Manufacturer: VELOCIMED INC.
Device Classification Name: temporary coronary saphenous vein bypass graft for embolic protection
Regulation Number: 870.1250
Classification Product Code: NFA
Date Received: 09/14/2005
Decision Date: 09/07/2006
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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