Data / Medical devices / Mexico / Cordis de Mexico, SA de CV

Cordis de Mexico, SA de CV: FDA-registered device maker in JUAREZ Chihuahua, Mexico, 44 510(k) clearances and 8 PMA approvals

Name: Cordis de Mexico, SA de CV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cordis de Mexico, SA de CV is registered with the FDA (registration 9673241) in JUAREZ Chihuahua, Mexico. It lists 12 device types. The FDA files 44 510(k) clearances and 8 PMA approvals under its listings, the newest dated November 6, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9673241
FEI number: 3003248396
Address: CIRCUITO INTERIOR NORTE, No. 1820 PARQUE INDUSTRIAL SALVARCAR, JUAREZ Chihuahua, Mexico, 32574
Owner or operator: BIOSENSE WEBSTER, INC. (9044811)
Roles: Manufacturer
First device listed: November 28, 2006
Registered through: 2027
Brand names listed: Biosense Webster LASSO Deflectable Mapping Catheter, Biosense Webster Patient Cable and Leadwires, CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES, CARTO 3 System eco Interface Cable, CARTO System Interface Cable, CELSIUS FLTR Catheter, CELSIUS® FLTR Diagnostic/Ablation Steerable Tip Catheters, CELSIUS® RMT Diagnostic/Ablation Steerable Tip Catheters and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Cardiac Ablation Percutaneous Catheter	LPB	3	Manufacturer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer	accessdata.fda.gov
Catheter, Flow Directed	DYG	2	Manufacturer	accessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density Array	MTD	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Manufacturer	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 28, 2024	K241540	NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter	OBJ	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 10, 2023	K231312	PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 2, 2023	K230253	OPTRELL Mapping Catheter with TRUEref Technology	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
February 16, 2023	K223766	NUVISION NAV Ultrasound Catheter	OBJ	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 18, 2022	K211438	OPTRELL Mapping Catheter with TRUEref Technology	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
January 26, 2022	K211219	LASSOSTAR NAV Circular Mapping Catheter	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 5, 2021	K201775	NuVision ICE Catheter	OBJ	Substantially Equivalent	Nuvera Medical, Inc.	accessdata.fda.gov
August 6, 2020	K201750	Pentaray Nav eco High-Density Mapping Catheter	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 31, 2020	K193237	Carto Octaray Mapping Catheter with Trueref Technology	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
June 30, 2020	K193632	LassoStar Circular Mapping Catheter	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
August 14, 2013	K130602	LASSO NAV DUO LOOP CATHETER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 5, 2013	K123837	PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
May 24, 2012	K120425	PENTARAY NAV HIGH-DENSITY MAPPING CATHETER	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
December 5, 2011	K113213	LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
May 2, 2011	K101991	WEBSTER DUO-DECAPOLAR CATHETER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
June 22, 2010	K101345	WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
June 18, 2010	K093376	LASSO NAV CATHETER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
October 13, 2009	K090017	CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES	DQK	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
September 4, 2009	K090898	CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 24, 2009	K090120	REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
January 6, 2009	K081258	VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
April 23, 2008	K080425	CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
August 14, 2006	K061468	REFSTAR EXTERNAL REFERENCE PATCH	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
August 14, 2006	K061463	ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
September 29, 2005	K052083	NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
September 29, 2005	K042998	REFSTAR RMT EXTERNAL REFERENCE PATCH	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
June 24, 2005	K050877	CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
March 30, 2005	K050217	FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 22, 2003	K031161	VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
August 31, 2000	K002333	BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220	DRF	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 21, 2000	K001390	BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES	DSA	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
May 10, 2000	K001139	PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M	DYB	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
November 26, 1999	K992965	CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
October 4, 1999	K991531	CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
August 28, 1998	K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S	DYB	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
August 10, 1998	K982415	CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
May 28, 1998	K980961	CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
October 28, 1997	K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	DYB	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
September 18, 1996	K953663	CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
March 25, 1996	K955817	CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
November 22, 1995	K953768	CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	Substantially Equivalent	Cordis Webster, Inc.	accessdata.fda.gov
December 3, 1985	K853383	CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN	DYG	Substantially Equivalent	Webster Laboratories, Inc.	accessdata.fda.gov
October 18, 1984	K841802	ELECTRODE CATHETER, ORTHOGONAL TYPE	LDF	Substantially Equivalent	Webster Laboratories, Inc.	accessdata.fda.gov
May 9, 1984	K834602	SWITCHING UNIT ELECTRODE CATHETER	DRF	Substantially Equivalent	Webster Laboratories, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 6, 2024	P240006	VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump)	QZI	16	September 15, 2026	accessdata.fda.gov
November 23, 2022	P210027	QDOT MICRO System	OAE	18	September 15, 2026	accessdata.fda.gov
August 11, 2006	P040036	NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER	LPB	92	September 15, 2026	accessdata.fda.gov
November 5, 2004	P030031	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	OAD	135	September 15, 2026	accessdata.fda.gov
September 27, 2002	P010068	NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER	OAD	73	February 26, 2025	accessdata.fda.gov
June 15, 2000	P990025	NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	DRF	72	February 25, 2025	accessdata.fda.gov
May 31, 2000	P990071	STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR	LPB	65	December 23, 2025	accessdata.fda.gov
September 30, 1997	P950005	WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER	LPB	86	February 26, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 2, 2008	50784	Not yet classified	Terminated	Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02	Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT scr	accessdata.fda.gov

Compare with other makers

Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.