The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Hydro-select Guidewire.
| Device ID | K954642 |
| 510k Number | K954642 |
| Device Name: | HYDRO-SELECT GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Jodi Locher |
| Correspondent | Jodi Locher MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-12-17 |
| Summary: | summary |