The following data is part of a premarket notification filed by Surmodics Inc. with the FDA for Pounce Thrombectomy System.
| Device ID | K220501 |
| 510k Number | K220501 |
| Device Name: | Pounce Thrombectomy System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| 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 | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-03-23 |