The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexfinder Guidewire.
| Device ID | K942074 |
| 510k Number | K942074 |
| Device Name: | FLEXFINDER GUIDEWIRE |
| Classification | Accessories, Catheter, G-u |
| 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 | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-06-24 |