The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Guidewire.
| Device ID | K893626 |
| 510k Number | K893626 |
| Device Name: | FLEXMEDICS GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | FLEXMEDICS 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance Bundy |
| Correspondent | Constance Bundy FLEXMEDICS 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-11 |
| Decision Date | 1989-09-26 |