The following data is part of a premarket notification filed by Vascular Solutions with the FDA for Wattson Temporary Pacing Guidewire.
| Device ID | K192454 |
| 510k Number | K192454 |
| Device Name: | Wattson Temporary Pacing Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Nancy Frame |
| Correspondent | Nancy Frame Vascular Solutions 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 | 2019-09-09 |
| Decision Date | 2020-01-15 |