The following data is part of a premarket notification filed by Surmodics, Inc. with the FDA for Pounce Thrombus Retrieval System.
| Device ID | K192814 |
| 510k Number | K192814 |
| Device Name: | Pounce Thrombus Retrieval System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 |
| Contact | Amy Yanta |
| Correspondent | Amy Yanta Surmodics, Inc. 9924 West 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 | 2019-10-01 |
| Decision Date | 2020-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812339030296 | K192814 | 000 |