Data / Medical devices / Mexico / Cardinal Health Mexico 244 S de RL de CV

Cardinal Health Mexico 244 S de RL de CV: FDA-registered device maker in Ciudad Juarez Chihuahua, Mexico, 24 510(k) clearances and 3 PMA approvals

Name: Cardinal Health Mexico 244 S de RL de CV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cardinal Health Mexico 244 S de RL de CV is registered with the FDA (registration 9616099) in Ciudad Juarez Chihuahua, Mexico. It lists 15 device types. The FDA files 24 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 21, 2023. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Cardinal Health Mexico 244 S de RL de CV

FDA registration number: 9616099
FEI number: 3003528016
Address: Santiago Troncoso #808 PARQUE INDUSTRIAL SALVARCAR, Ciudad Juarez Chihuahua, Mexico, CP 32575
Owner or operator: Cordis US Corp. (1016427)
Roles: Contract manufacturer, Manufacturer
First device listed: March 2, 2006
Registered through: 2027
Brand names listed: 4F & 5F Nylex Diagnostic Catheters, 4F & 5F Tempo Diagnostic Catheters, 4F Infiniti Diagnostic Catheter, 4F Super Torque Diagnostic Catheter, 4F Tempo Aqua Diagnostic Catheter, 5.2F Super Torque Plus Diagnostic Catheter, 5F & 6F Infiniti Diagnostic Catheter, 5F ADROIT Guiding Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiac Catheterization Kit	OES	2	Manufacturer	accessdata.fda.gov
Cardiovascular Procedure Kit	OEZ	2	Manufacturer	accessdata.fda.gov
Catheter For Crossing Total Occlusions	PDU	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Hemostasis, Vascular	MGB	3	Contract manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Manufacturer	accessdata.fda.gov
Filter, Intravascular, Cardiovascular	DTK	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Stent, Carotid	NIM	3	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm Treatment	MIH	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
November 21, 2023	K232573	INFINITI Ambi Angiographic Catheter	DQO	Substantially Equivalent	Cordis US Corp	accessdata.fda.gov
February 17, 2022	K212977	SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands	DQO	Substantially Equivalent	Cordis Corporation	accessdata.fda.gov
August 8, 2018	K181836	4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters	DQO	Substantially Equivalent	Cordis, A Cardinal Health Company	accessdata.fda.gov
January 14, 2015	K143412	ADROIT Guiding Catheter	DQY	Substantially Equivalent	Cordis Corporation	accessdata.fda.gov
May 29, 2013	K131225	ADROIT GUIDING CATHETER	DQY	Substantially Equivalent	Cordis Corp., A Johnson & Johnson Co.	accessdata.fda.gov
February 6, 2008	K062798	SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB	FGE	Unknown	Cordis Corp.	accessdata.fda.gov
November 8, 2004	K042969	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	Unknown	Cordis Corp.	accessdata.fda.gov
July 7, 2003	K031777	MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	Unknown	Cordis Corp.	accessdata.fda.gov
June 13, 2002	K021593	MODIFICATION TO ENVOY AND VISTA BRITE TIP	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
May 3, 2000	K000579	TEMPO AQUA ANGIOGRAPHIC CATHETER	DQO	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
March 31, 2000	K000715	ENVOY AND VISTA BRITE TIP	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
October 12, 1999	K992673	VISTA BRITE TIP CATHETERS	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
October 21, 1997	K972978	VISTA BRITE TIP GUIDING CATHETERS	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
September 30, 1997	K970854	5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER	DQO	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
July 23, 1997	K965247	ENVOY GUIDING CATHETER	DQY	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
July 14, 1997	K971572	VISTA BRITE TIP CATHETERS	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
May 7, 1997	K963962	VISTA BRITE TIP CATHETERS	DQY	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
April 24, 1997	K970392	CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM	DRE	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
October 11, 1996	K962746	CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT	DYB	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
February 11, 1992	K915836	CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS	DQO	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
November 22, 1991	K914352	CORDIS OBTURATOR	DYB	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
October 18, 1991	K914007	CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH	DQO	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
June 27, 1986	K862006	STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH	DQO	Substantially Equivalent	Cordis Corp.	accessdata.fda.gov
August 20, 1981	K812231	INTRAVENOUS ADMINISTRATION SET	FPA	Substantially Equivalent	Cordis Corp.	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 7, 2012	P120002	SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS	NIP	33	October 15, 2026	accessdata.fda.gov
September 22, 2006	P030047	CORDIS PRECISE NITINOL STENT SYSTEM	NIM	51	June 5, 2026	accessdata.fda.gov
August 12, 2003	P020036	S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM	NIO	57	October 15, 2026	accessdata.fda.gov

Compare with other makers

Updated October 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.