510(k) K082873

MEDTRONIC ANGIOGRAPHIC GUIDE WIRES by Medtronic Vascular — Product Code DQX

K082873 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC ANGIOGRAPHIC GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
September 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type