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FDA 510(k), K153485, ENROUTE Transcarotid Neuroprotection System
FDA 510(k), K153485, ENROUTE Transcarotid Neuroprotection System
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510(K) Number: K153485
Device Name: ENROUTE Transcarotid Neuroprotection System
Manufacturer: SILK ROAD MEDICAL, INC.
Device Classification Name: temporary carotid catheter for embolic capture
Regulation Number: 870.1250
Classification Product Code: NTE
Date Received: 12/03/2015
Decision Date: 03/10/2016
Regulation Medical Specialty: Cardiovascular
Device Name: ENROUTE Transcarotid Neuroprotection System
Manufacturer: SILK ROAD MEDICAL, INC.
Device Classification Name: temporary carotid catheter for embolic capture
Regulation Number: 870.1250
Classification Product Code: NTE
Date Received: 12/03/2015
Decision Date: 03/10/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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