The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Cohen Crossover Catheter.
| Device ID | K101625 |
| 510k Number | K101625 |
| Device Name: | COHEN CROSSOVER CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-07-19 |
| Summary: | summary |