K130649 is an FDA 510(k) clearance for the SILK ROAD ACCESS CATHETER. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Silk Road Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 1, 2013, 235 days after receiving the submission on March 11, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K130649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2013 |
| Decision Date | November 01, 2013 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |