The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vsi Guidewire.
| Device ID | K112631 |
| 510k Number | K112631 |
| Device Name: | VSI GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Melinda Swanson |
| Correspondent | Melinda Swanson VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2011-10-27 |
| Summary: | summary |