FDA 510(k) Applications Submitted by ABBOTT VASCULAR

FDA 510(k) Number Submission Date Device Name Applicant
K173795 12/14/2017 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular
K153086 10/26/2015 RX ACCUNET Embolic Protection System ABBOTT VASCULAR
K112239 08/04/2011 STEERABLE GUIDE CATHETER Abbott Vascular
K180040 01/05/2018 NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI Abbott Vascular
K121015 04/04/2012 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular
K121352 05/04/2012 ARMADA 14XXT PTA CATHETER Abbott Vascular
K141678 06/23/2014 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular
K152709 09/21/2015 HI-TORQUE BALANCE ABBOTT VASCULAR
K172073 07/10/2017 Hi-Torque Command 18 Guide Wire Abbott Vascular
K111899 07/05/2011 ARMADA 35/35LL PTA CATHETER Abbott Vascular
K161985 07/19/2016 Steerable Guide Catheter ABBOTT VASCULAR
K172394 08/08/2017 Steerable Guide Catheter Abbott Vascular
K092286 07/29/2009 FOX SV PTA CATHETER Abbott Vascular
K083706 12/15/2008 HI-TORQUE VERSACORE GUIDE WIRE Abbott Vascular
K083713 12/15/2008 .035 LOC GUIDE WIRE EXTENSION Abbott Vascular
K083732 12/16/2008 TAD AND TAD II TAPERED GUIDE WIRES Abbott Vascular
K083738 12/16/2008 HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 Abbott Vascular
K151317 05/18/2015 Armada 18 PTA Catheter ABBOTT VASCULAR
K152404 08/25/2015 Hi-Torque Command 18 Guide Wire ABBOTT VASCULAR
K110617 03/03/2011 MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER Abbott Vascular
K121222 04/23/2012 TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER Abbott Vascular
K123279 10/22/2012 MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN Abbott Vascular
K113464 11/22/2011 NC TREK OTW CORONARY DILATATION CATHETER Abbott Vascular
K141782 07/02/2014 HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular


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