The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for Turnpike Catheter, Turnpike Spiral Catheter, Turnpike Lp Catheter, Turnpike Gold Catheter, Guideliner V3 Catheter, Trapliner Catheter.
| Device ID | K212211 |
| 510k Number | K212211 |
| Device Name: | Turnpike Catheter, Turnpike Spiral Catheter, Turnpike LP Catheter, Turnpike Gold Catheter, GuideLiner V3 Catheter, TrapLiner Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, MN 55369 |
| Contact | Rebecca Astrup |
| Correspondent | Rebecca Astrup Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, 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 | 2021-07-15 |
| Decision Date | 2022-02-09 |