510(k) K961917

MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) by Medtronics Interventional Vascular — Product Code DQX

K961917 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)". The FDA issued a decision of Substantially Equivalent on November 20, 1996. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1996
Date Received
May 17, 1996
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