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

Medtronic Vascular — Predicate Candidate Screening

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

74 daysmedian FDA review time

216 days90th percentile

475clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232570	Steerant™ Super Stiff Guidewire	Medtronic Vascular	2023-10-24	61	0
K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced	Medtronic Vascular	2023-08-22	29	0
K230156	5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F L	Medtronic Vascular	2023-06-30	162	0
K220773	Everest 20 Inflation Device and 3-way Stopcock (AC2200);Ever	Medtronic Vascular	2022-04-13	28	0
K192296	Medtronic 6F Taiga Guiding Catheter	Medtronic Vascular	2019-09-20	28	0
K173515	Admiral Xtreme	Medtronic Vascular	2018-04-12	149	0
K162097	InTRAkit	Medtronic Vascular	2016-11-17	111	0
K162027	TRAcelet Compression Device	Medtronic Vascular	2016-10-21	91	0
K161287	DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak,	Medtronic Vascular	2016-08-19	102	1
K133539	TOTAL ACROSS	Medtronic Vascular	2014-03-26	128	0
K123990	SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING	Medtronic Vascular	2013-04-26	121	0
K123358	PACIFIC PLUS	Medtronic Vascular	2013-01-29	90	0
K101777	PIONEER PLUS CATHETER, MODEL PLUS 120	Medtronic Vascular	2010-07-23	28	1
K091582	GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15	Medtronic Vascular	2009-12-04	185	1
K082873	MEDTRONIC ANGIOGRAPHIC GUIDE WIRES	Medtronic Vascular	2009-02-06	130	0
K083422	6F TAIGA GUIDING CATHETER	Medtronic Vascular	2009-02-06	79	1
K081573	MEDTRONIC EXPORT AP CATHETER	Medtronic Vascular	2008-06-27	22	0
K062264	COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM	Medtronic Vascular	2007-11-08	461	3
K071253	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CAR	Medtronic Vascular	2007-07-03	60	2
K070288	CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL,	Medtronic Vascular	2007-06-18	139	0
K070311	CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AN	Medtronic Vascular	2007-04-24	82	0
K061416	SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59	Medtronic Vascular	2006-10-25	156	0
K062727	CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE	Medtronic Vascular	2006-10-11	28	0
K062420	5F SHERPA ACTIVE NX GUIDE CATHETER	Medtronic Vascular	2006-09-08	21	0
K061958	MEDTRONIC EXPORT XT CATHETER	Medtronic Vascular	2006-09-05	56	1
K062057	U-CLIP DEVICE, MODEL NC65	Medtronic Vascular	2006-08-02	13	0
K061127	CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R	Medtronic Vascular	2006-05-23	29	0
K060418	8F SHERPA NX GUIDE CATHETER	Medtronic Vascular	2006-03-15	26	0
K052459	6248VAL ADJUSTABLE VALVE	Medtronic Vascular	2006-01-11	126	1
K051386	MASTERGRAFT PUTTY BONE VOID FILLER	Medtronic Vascular	2005-12-16	203	0
K053252	U-CLIP DEVICE, MODELS B140, B160 AND B180	Medtronic Vascular	2005-12-16	25	0
K052413	TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934	Medtronic Vascular	2005-11-17	76	1
K051846	7F SHERPA NX GUIDE CATHETER	Medtronic Vascular	2005-08-05	29	0
K050139	MODIFICATION TO: EXPORT CATHETER	Medtronic Vascular	2005-03-22	60	0
K043291	CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL	Medtronic Vascular	2004-12-21	22	0
K042489	6F Z4 GUIDE CATHETER	Medtronic Vascular	2004-12-13	90	191
K043080	HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR	Medtronic Vascular	2004-12-03	25	0
K042206	PURPLE/BLACK HEPARIN ASSAY CONTROL	Medtronic Vascular	2004-10-18	63	0
K042175	HEPARINASE HR ACT CONTROL, MODEL 550-12	Medtronic Vascular	2004-10-18	68	0
K042070	HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20	Medtronic Vascular	2004-10-01	60	0
K042194	ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELI	Medtronic Vascular	2004-09-15	34	0
K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	Medtronic Vascular	2004-09-07	26	0
K040812	DETECT SURGICAL PACING AND MAPPING TOOL	Medtronic Vascular	2004-09-02	157	0
K041244	POLYGRAM NET BIOFEEDBACK APPLICATION	Medtronic Vascular	2004-08-12	93	0
K041338	MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES	Medtronic Vascular	2004-07-19	60	0
K040869	EXPORT CATHETER	Medtronic Vascular	2004-06-01	60	0
K033540	TRANSXCHANGE SUPPORT CATHETER	Medtronic Vascular	2004-05-25	197	0
K033050	EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL	Medtronic Vascular	2004-03-26	179	0
K040568	POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS	Medtronic Vascular	2004-03-25	21	0
K034058	SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011	Medtronic Vascular	2004-01-29	30	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