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FDA 510(k), K094044, SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
FDA 510(k), K094044, SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
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510(K) Number: K094044
Device Name: SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
Manufacturer: TAYSIDE FLOW TECHNOLOGIES LIMITED
Device Classification Name: prosthesis, vascular graft, of 6mm and greater diameter
Regulation Number: 870.3450
Classification Product Code: DSY
Date Received: 12/31/2009
Decision Date: 03/23/2010
Regulation Medical Specialty: Cardiovascular
Device Name: SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
Manufacturer: TAYSIDE FLOW TECHNOLOGIES LIMITED
Device Classification Name: prosthesis, vascular graft, of 6mm and greater diameter
Regulation Number: 870.3450
Classification Product Code: DSY
Date Received: 12/31/2009
Decision Date: 03/23/2010
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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