The following data is part of a premarket notification filed by Vascular Solutions, Inc with the FDA for Warrior 14 Guidewire.
| Device ID | K180128 |
| 510k Number | K180128 |
| Device Name: | Warrior 14 Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Vascular Solutions, Inc 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Becky Astrup |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841156101156 | K180128 | 000 |