The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for M2 Navigation Catheter And Guideliner Navigation Catheter.
| Device ID | K112100 |
| 510k Number | K112100 |
| Device Name: | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Matt Nienstedt |
| Correspondent | Matt Nienstedt VASCULAR SOLUTIONS, INC. 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 | 2011-07-22 |
| Decision Date | 2012-03-20 |
| Summary: | summary |