The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike Lp Catheter.
| Device ID | K191560 |
| 510k Number | K191560 |
| Device Name: | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Beka Vite |
| Correspondent | Beka Vite Vascular Solutions LLC 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 | 2019-06-13 |
| Decision Date | 2019-08-09 |