The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Angiographic Guide Wires.
Device ID | K082873 |
510k Number | K082873 |
Device Name: | MEDTRONIC ANGIOGRAPHIC GUIDE WIRES |
Classification | Wire, Guide, Catheter |
Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
Contact | Tara N Turney |
Correspondent | Tara N Turney 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 | 2008-09-29 |
Decision Date | 2009-02-06 |
Summary: | summary |