The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for Guideliner Coast, 5.5f (5270); Guideliner Coast, 6f (5271); Guideliner Coast, 7f (5272); Guideliner Coast, 8f (5273).
| Device ID | K220647 |
| 510k Number | K220647 |
| Device Name: | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) |
| Classification | Catheter, Percutaneous |
| Applicant | Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, MN 55369 |
| Contact | Steph Pahl |
| Correspondent | Steph Pahl Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-08-18 |