The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Gtx Guidewire, Models Tbd-gtx 1, 3,6,9,12, 15.
| Device ID | K091582 |
| 510k Number | K091582 |
| Device Name: | GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Colleen Mullins |
| Correspondent | Colleen Mullins MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-12-04 |
| Summary: | summary |