The following data is part of a premarket notification filed by Vascular Medcure, Inc. with the FDA for Capere Thrombectomy System.
| Device ID | K183179 |
| 510k Number | K183179 |
| Device Name: | CAPERE Thrombectomy System |
| Classification | Catheter, Embolectomy |
| Applicant | Vascular Medcure, Inc. 1500 S. Sunkist St. - Suite H Anaheim, CA 92806 |
| Contact | Jeffrey P. Dumontelle |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-02-25 |
| Summary: | summary |