The following data is part of a premarket notification filed by Microvena Corp. with the FDA for .25' Ultra-select Guidewire.
| Device ID | K922060 |
| 510k Number | K922060 |
| Device Name: | .25' ULTRA-SELECT GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICROVENA CORP. 3600 LABORE RD. #1 Vadnais Heights, MN 55110 |
| Contact | Michael Renner |
| Correspondent | Michael Renner MICROVENA CORP. 3600 LABORE RD. #1 Vadnais Heights, MN 55110 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1993-02-23 |