The following data is part of a premarket notification filed by Flexmedics with the FDA for Finesse Guidewire Coronary.
| Device ID | K952430 |
| 510k Number | K952430 |
| Device Name: | FINESSE GUIDEWIRE CORONARY |
| Classification | Wire, Guide, Catheter |
| Applicant | FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Contact | Debra K Fritz |
| Correspondent | Debra K Fritz FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-24 |
| Decision Date | 1995-08-18 |