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

Biosense Webster, Inc. — Predicate Candidate Screening

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

99 daysmedian FDA review time

272 days90th percentile

73clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252972	CARTO™ 3 EP Navigation System V8.4	Biosense Webster, Inc.	2026-02-20	156	0
K254085	CARTO™ 3 EP Navigation System V9.0 with PIU Plus	Biosense Webster, Inc.	2026-01-18	31	0
K252302	CARTO™ 3 EP Navigation System V8.1	Biosense Webster, Inc.	2025-08-22	29	0
K241540	NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Cath	Biosense Webster, Inc.	2024-06-28	28	0
K240050	SOUNDSTAR™ CRYSTAL Ultrasound Catheter	Biosense Webster, Inc.	2024-06-12	156	0
K231207	CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-	Biosense Webster, Inc.	2023-09-07	133	0
K231312	PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Ma	Biosense Webster, Inc.	2023-07-10	66	0
K231412	CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-	Biosense Webster, Inc.	2023-07-10	55	0
K230253	OPTRELL™ Mapping Catheter with TRUEref™ Technology	Biosense Webster, Inc.	2023-03-02	30	0
K223733	CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.	Biosense Webster, Inc.	2023-02-16	65	0
K223766	NUVISION™ NAV Ultrasound Catheter	Biosense Webster, Inc.	2023-02-16	63	0
K221112	CARTO 3 EP Navigation System with Advanced Focus Mapping (AF	Biosense Webster, Inc.	2022-08-17	124	0
K211438	OPTRELL Mapping Catheter with TRUEref Technology	Biosense Webster, Inc.	2022-03-18	312	0
K211219	LASSOSTAR NAV Circular Mapping Catheter	Biosense Webster, Inc.	2022-01-26	278	0
K213264	CARTO 3 EP Navigation System Version 7.2	Biosense Webster, Inc.	2021-10-29	29	0
K200484	CARTO® 3 EP Navigation System with Signal Processing Unit	Biosense Webster, Inc.	2020-11-25	272	0
K201750	Pentaray Nav eco High-Density Mapping Catheter	Biosense Webster, Inc.	2020-08-06	41	0
K193237	Carto Octaray Mapping Catheter with Trueref Technology	Biosense Webster, Inc.	2020-07-31	249	0
K193632	LassoStar Circular Mapping Catheter	Biosense Webster, Inc.	2020-06-30	186	0
K191660	CARTO 3 EP Navigation System, Version 7.1 and Accessories	Biosense Webster, Inc.	2019-07-20	29	0
K173978	CARTO 3 EP Navigation System, Version 5.2 and Accessories wi	Biosense Webster, Inc.	2018-08-24	238	0
K173977	CARTO 3 EP Navigation System, Version 4.35 and Accessories w	Biosense Webster, Inc.	2018-06-14	167	0
K180238	CARTO 3 EP Navigation System, Version 6.0 and Accessories wi	Biosense Webster, Inc.	2018-06-01	123	0
K170600	CARTO 3 EP Navigation System, Version 6.0 and Accessories	Biosense Webster, Inc.	2017-07-25	146	0
K170997	CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath	Biosense Webster, Inc.	2017-07-25	113	3
K133916	CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2	Biosense Webster, Inc.	2014-07-01	190	2
K132782	CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2	Biosense Webster, Inc.	2014-01-24	140	1
K130602	LASSO NAV DUO LOOP CATHETER	Biosense Webster, Inc.	2013-08-14	160	1
K123837	PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER	Biosense Webster, Inc.	2013-03-05	82	1
K120425	PENTARAY NAV HIGH-DENSITY MAPPING CATHETER	Biosense Webster, Inc.	2012-05-24	101	1
K120550	CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LO	Biosense Webster, Inc.	2012-05-07	74	2
K113213	LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER	Biosense Webster, Inc.	2011-12-05	34	1
K112050	SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER	Biosense Webster, Inc.	2011-11-18	123	0
K112007	CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2	Biosense Webster, Inc.	2011-10-05	83	2
K101991	WEBSTER DUO-DECAPOLAR CATHETER	Biosense Webster, Inc.	2011-05-02	292	0
K103746	CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATI	Biosense Webster, Inc.	2011-01-21	29	1
K101345	WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CAT	Biosense Webster, Inc.	2010-06-22	40	1
K101138	SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12	Biosense Webster, Inc.	2010-06-22	61	0
K093566	CARTO XP EP NAVIGATION SYSTEM, VERSION 10	Biosense Webster, Inc.	2010-06-18	212	0
K093376	LASSO NAV CATHETER	Biosense Webster, Inc.	2010-06-18	232	0
K091352	SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05	Biosense Webster, Inc.	2009-12-04	211	0
K093455	CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES	Biosense Webster, Inc.	2009-12-04	29	1
K090017	CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES	Biosense Webster, Inc.	2009-10-13	284	4
K091789	CARTO RMT EP NAVIGATION SYSTEM V8	Biosense Webster, Inc.	2009-10-01	106	0
K090898	CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01	Biosense Webster, Inc.	2009-09-04	156	1
K092064	SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12	Biosense Webster, Inc.	2009-08-07	30	0
K090120	REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL	Biosense Webster, Inc.	2009-03-24	62	0
K081258	VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02	Biosense Webster, Inc.	2009-01-06	249	0
K080425	CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND	Biosense Webster, Inc.	2008-04-23	68	0
K072202	CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERN	Biosense Webster, Inc.	2007-11-19	103	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