The following data is part of a premarket notification filed by Vascular Medcure, Inc. with the FDA for Capere Thrombectomy System.
| Device ID | K192935 |
| 510k Number | K192935 |
| Device Name: | CAPERE Thrombectomy System |
| Classification | Mechanical Thrombolysis Catheter |
| Applicant | Vascular Medcure, Inc. 1500 S. Sunkist St. - Suite H Anaheim, CA 92806 |
| Contact | Jeffrey P Dumontelle |
| Correspondent | Janice M Hogan Hogan & Lovells US LPP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | QEY |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2019-11-15 |