510(k) K060449

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE by Guidant Corporation — Product Code DQX

K060449 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on May 30, 2006. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Guidant Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2006
Date Received
February 21, 2006
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