The following data is part of a premarket notification filed by Microvena Corp. with the FDA for M-path Nitinol Guidewire.
| Device ID | K946356 |
| 510k Number | K946356 |
| Device Name: | M-PATH NITINOL 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 | 1994-12-30 |
| Decision Date | 1995-03-31 |