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 |