The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire.
| Device ID | K140695 |
| 510k Number | K140695 |
| Device Name: | COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC INC. 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Nisarg Shah |
| Correspondent | Nisarg Shah MEDTRONIC INC. 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 | 2014-03-19 |
| Decision Date | 2014-06-12 |
| Summary: | summary |