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FDA 510(k), K092863, MAXIFLO, TAPERFLO
FDA 510(k), K092863, MAXIFLO, TAPERFLO
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510(K) Number: K092863
Device Name: MAXIFLO, TAPERFLO
Manufacturer: VASCUTEK LTD.
Device Classification Name: prosthesis, vascular graft, of 6mm and greater diameter
Regulation Number: 870.3450
Classification Product Code: DSY
Date Received: 09/17/2009
Decision Date: 10/08/2009
Regulation Medical Specialty: Cardiovascular
Device Name: MAXIFLO, TAPERFLO
Manufacturer: VASCUTEK LTD.
Device Classification Name: prosthesis, vascular graft, of 6mm and greater diameter
Regulation Number: 870.3450
Classification Product Code: DSY
Date Received: 09/17/2009
Decision Date: 10/08/2009
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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