The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Turnpike Catheter.
| Device ID | K142065 |
| 510k Number | K142065 |
| Device Name: | TURNPIKE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Ellie Gillespie |
| Correspondent | Ellie Gillespie VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North 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 | 2014-07-30 |
| Decision Date | 2014-11-25 |
| Summary: | summary |