Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Vascular

30 submissions · 30 cleared · Since 2009
30
Total
30
Cleared
0
Denied

Abbott Vascular — FDA 510(k) Submissions

Abbott Vascular has submitted 30 FDA 510(k) premarket notifications since 2009, of which 30 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, Catheters, Transluminal Coronary Angioplasty, Percutaneous, Catheter, Angioplasty, Peripheral, Transluminal, Temporary Carotid Catheter For Embolic Capture, Catheter, Steerable . Use the specialty filter in the sidebar to narrow results.

30 devices
1–25 of 30
NC TREK NEO Coronary Dilatation Catheter
K220634 · LOX Catheters, Transluminal... · Cardiovascular
Jun 2022 118d
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · LIT Catheter, Angioplasty,... · Cardiovascular
May 2022 24d
HI-TORQUE PROCEED Guide Wire Family
K201834 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2020 28d
HI-TORQUE Steelcore Bare Guide Wire
K200144 · DQX Wire, Guide, Catheter · Cardiovascular
Apr 2020 77d
HI-TORQUE InfilTrac Guide Wire Family
K193126 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2019 29d
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · NTE Temporary Carotid... · Cardiovascular
Jul 2019 85d
NC TREK? RX Coronary Dilatation Catheter; NC TREK? OTW Coronary Dilatation Catheter; TREK? RX Coronary Dilatation Catheter; TREK? OTW Coronary Dilatation Catheter; MINI TREK? RX Coronary Dilatation Catheter; MINI TREK? OTW Coronary Dilatation Catheter; MINI TREK? II OTW Coronary Dilatation Catheter
K180040 · LOX Catheters, Transluminal... · Cardiovascular
Aug 2018 231d
HI-TORQUE TurnTrac Guide Wire Family
K173795 · DQX Wire, Guide, Catheter · Cardiovascular
Jan 2018 29d
Steerable Guide Catheter
K172394 · DRA Catheter, Steerable · Cardiovascular
Sep 2017 29d
Hi-Torque Command 18 Guide Wire
K172073 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2017 46d
Steerable Guide Catheter
K161985 · DRA Catheter, Steerable · Cardiovascular
Aug 2016 19d
RX ACCUNET Embolic Protection System
K153086 · NTE Temporary Carotid... · Cardiovascular
Nov 2015 25d
HI-TORQUE BALANCE
K152709 · DQX Wire, Guide, Catheter · Cardiovascular
Oct 2015 30d
Hi-Torque Command 18 Guide Wire
K152404 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2015 27d
Armada 18 PTA Catheter
K151317 · LIT Catheter, Angioplasty,... · Cardiovascular
Jul 2015 49d
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2014 36d
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE Temporary Carotid... · Cardiovascular
Jul 2014 29d
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
K123279 · LOX Catheters, Transluminal... · Cardiovascular
Jan 2013 100d
ARMADA 14XXT PTA CATHETER
K121352 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2012 103d
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · LOX Catheters, Transluminal... · Cardiovascular
Jun 2012 60d
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · NTE Temporary Carotid... · Cardiovascular
May 2012 30d
NC TREK OTW CORONARY DILATATION CATHETER
K113464 · LOX Catheters, Transluminal... · Cardiovascular
Mar 2012 105d
ARMADA 35/35LL PTA CATHETER
K111899 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2011 90d
STEERABLE GUIDE CATHETER
K112239 · DRA Catheter, Steerable · Cardiovascular
Aug 2011 27d
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
K110617 · LOX Catheters, Transluminal... · Cardiovascular
Jun 2011 91d
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