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FDA 510(k), K130649, SILK ROAD ACCESS CATHETER
FDA 510(k), K130649, SILK ROAD ACCESS CATHETER
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510(K) Number: K130649
Device Name: SILK ROAD ACCESS CATHETER
Manufacturer: SILK ROAD MEDICAL, INC
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 03/11/2013
Decision Date: 11/01/2013
Regulation Medical Specialty: Cardiovascular
Device Name: SILK ROAD ACCESS CATHETER
Manufacturer: SILK ROAD MEDICAL, INC
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 03/11/2013
Decision Date: 11/01/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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