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 | K153485 |
| 510k Number | K153485 |
| Device Name: | ENROUTE Transcarotid Neuroprotection System |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | SILK ROAD MEDICAL, INC. 735 NORTH PASTORIA AVENUE Sunnyvale, CA 94085 |
| Contact | Kristin Ellis |
| Correspondent | Kristin Ellis SILK ROAD MEDICAL, INC. 735 NORTH PASTORIA AVENUE 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 | 2015-12-03 |
| Decision Date | 2016-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811311020829 | K153485 | 000 |
| 00811311020775 | K153485 | 000 |
| 00811311020744 | K153485 | 000 |