510(k) K123067

PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY by Abbott Vascular, Inc. — Product Code DQX

K123067 is an FDA 510(k) premarket notification submitted by Abbott Vascular, Inc. for the device "PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY". The FDA issued a decision of Substantially Equivalent on January 29, 2013. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Abbott Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2013
Date Received
October 1, 2012
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