510(k) K141782

HI-TORQUE VERSATURN GUIDE WIRE by Abbott Vascular — Product Code DQX

K141782 is an FDA 510(k) premarket notification submitted by Abbott Vascular for the device "HI-TORQUE VERSATURN GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Abbott Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
July 2, 2014
Clearance Type
Special
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