The following data is part of a premarket notification filed by Silk Road Medical, Inc with the FDA for Silk Road Access Catheter.
| Device ID | K130649 |
| 510k Number | K130649 |
| Device Name: | SILK ROAD ACCESS CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-11-01 |
| Summary: | summary |