The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions Twin-pass Dual Access Catheter And Skyway Support Catheter.
| Device ID | K060327 |
| 510k Number | K060327 |
| Device Name: | VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Julie Tapper |
| Correspondent | Julie Tapper VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-04-12 |
| Summary: | summary |