The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Guideliner Catheter, Models 5571, 5572, 5573.
| Device ID | K091750 |
| 510k Number | K091750 |
| Device Name: | GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Loucinda Bjorklund |
| Correspondent | Loucinda Bjorklund 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 | 2009-06-16 |
| Decision Date | 2009-11-04 |
| Summary: | summary |