Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Abbott Vascular — Predicate Candidate Screening

30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time

105 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220634	NC TREK NEO Coronary Dilatation Catheter	Abbott Vascular	2022-06-30	118	0
K221057	Viatrac 14 Plus Peripheral Dilatation Catheter	Abbott Vascular	2022-05-05	24	0
K201834	HI-TORQUE PROCEED Guide Wire Family	Abbott Vascular	2020-07-30	28	0
K200144	HI-TORQUE Steelcore Bare Guide Wire	Abbott Vascular	2020-04-08	77	0
K193126	HI-TORQUE InfilTrac Guide Wire Family	Abbott Vascular	2019-12-11	29	0
K191173	Emboshield NAV6 Embolic Protection System, Barewire Filter D	Abbott Vascular	2019-07-25	85	0
K180040	NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coron	Abbott Vascular	2018-08-24	231	0
K173795	HI-TORQUE TurnTrac Guide Wire Family	Abbott Vascular	2018-01-12	29	0
K172394	Steerable Guide Catheter	Abbott Vascular	2017-09-06	29	0
K172073	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2017-08-25	46	0
K161985	Steerable Guide Catheter	Abbott Vascular	2016-08-07	19	0
K153086	RX ACCUNET Embolic Protection System	Abbott Vascular	2015-11-20	25	0
K152709	HI-TORQUE BALANCE	Abbott Vascular	2015-10-21	30	0
K152404	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2015-09-21	27	0
K151317	Armada 18 PTA Catheter	Abbott Vascular	2015-07-06	49	0
K141782	HI-TORQUE VERSATURN GUIDE WIRE	Abbott Vascular	2014-08-07	36	0
K141678	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM	Abbott Vascular	2014-07-22	29	0
K123279	MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM	Abbott Vascular	2013-01-30	100	0
K121352	ARMADA 14XXT PTA CATHETER	Abbott Vascular	2012-08-15	103	0
K121222	TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY	Abbott Vascular	2012-06-22	60	0
K121015	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM	Abbott Vascular	2012-05-04	30	0
K113464	NC TREK OTW CORONARY DILATATION CATHETER	Abbott Vascular	2012-03-06	105	0
K111899	ARMADA 35/35LL PTA CATHETER	Abbott Vascular	2011-10-03	90	1
K112239	STEERABLE GUIDE CATHETER	Abbott Vascular	2011-08-31	27	0
K110617	MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK	Abbott Vascular	2011-06-02	91	0
K092286	FOX SV PTA CATHETER	Abbott Vascular	2009-08-27	29	0
K083738	HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 A	Abbott Vascular	2009-03-11	85	0
K083732	TAD AND TAD II TAPERED GUIDE WIRES	Abbott Vascular	2009-02-25	71	0
K083713	.035 LOC GUIDE WIRE EXTENSION	Abbott Vascular	2009-02-23	70	0
K083706	HI-TORQUE VERSACORE GUIDE WIRE	Abbott Vascular	2009-02-06	53	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda