The following data is part of a premarket notification filed by Surmodics, Inc. with the FDA for Pounce Thrombectomy System.
| Device ID | K211492 |
| 510k Number | K211492 |
| Device Name: | Pounce Thrombectomy System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Surmodics, Inc. 9924 W 74th Street Eden Prairie, MN 55344 |
| Contact | Holly Ramirez |
| Correspondent | Holly Ramirez Surmodics, Inc. 9924 W 74th Street Eden Prairie, MN 55344 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-13 |
| Decision Date | 2021-07-30 |