The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Guidewire .012 Only.
| Device ID | K895899 |
| 510k Number | K895899 |
| Device Name: | FLEXMEDICS GUIDEWIRE .012 ONLY |
| Classification | Wire, Guide, Catheter |
| Applicant | FLEXMEDICS 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G 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 | 1989-10-06 |
| Decision Date | 1990-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684058091 | K895899 | 000 |
| 00821684058084 | K895899 | 000 |
| 20763000185835 | K895899 | 000 |
| 20763000185828 | K895899 | 000 |