The following data is part of a premarket notification filed by Surmodics Inc. with the FDA for Sublime Microcatheter.
| Device ID | K221886 |
| 510k Number | K221886 |
| Device Name: | Sublime Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Surmodics Inc. 7905 Golden Triangle Drive Suite 190 Eden Prairie, MN 55344 |
| Contact | Holly Ramirez |
| Correspondent | Holly Ramirez Surmodics Inc. 7905 Golden Triangle Drive Suite 190 Eden Prairie, MN 55344 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812339030746 | K221886 | 000 |
| 00812339030630 | K221886 | 000 |
| 00812339030623 | K221886 | 000 |
| 00812339030616 | K221886 | 000 |
| 00812339030609 | K221886 | 000 |
| 00812339030593 | K221886 | 000 |
| 00812339030586 | K221886 | 000 |
| 00812339030579 | K221886 | 000 |
| 00812339030562 | K221886 | 000 |
| 00812339030647 | K221886 | 000 |
| 00812339030654 | K221886 | 000 |
| 00812339030739 | K221886 | 000 |
| 00812339030722 | K221886 | 000 |
| 00812339030715 | K221886 | 000 |
| 00812339030708 | K221886 | 000 |
| 00812339030692 | K221886 | 000 |
| 00812339030685 | K221886 | 000 |
| 00812339030678 | K221886 | 000 |
| 00812339030661 | K221886 | 000 |
| 00812339030555 | K221886 | 000 |