The following data is part of a premarket notification filed by Silk Road Medical, Inc with the FDA for Enroute Transcarotid Neuroprotection System.
| Device ID | K143072 |
| 510k Number | K143072 |
| Device Name: | ENROUTE Transcarotid Neuroprotection System |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | SILK ROAD MEDICAL, INC 735 NORTH PASTORIA AVE Sunnyvale, CA 94085 |
| Contact | Richard M Ruedy |
| Correspondent | Richard M Ruedy SILK ROAD MEDICAL, INC 735 NORTH PASTORIA AVE Sunnyvale, CA 94085 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-27 |
| Decision Date | 2015-02-09 |
| Summary: | summary |