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 |