Data / Medical devices / Mexico / Quiroproductos de Cuauhtemoc S. De R.L. de C.V.

Quiroproductos de Cuauhtemoc S. De R.L. de C.V.: FDA-registered device maker in Cuauhtemoc Chihuahua, Mexico, 11 510(k) clearances

Name: Quiroproductos de Cuauhtemoc S. De R.L. de C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Quiroproductos de Cuauhtemoc S. De R.L. de C.V. is registered with the FDA (registration 3009750712) in Cuauhtemoc Chihuahua, Mexico. It lists 21 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 29, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009750712
Address: Av. Rio Chuviscar y Carretera A Anahuac No. 8950 Parque Industrial Cuauhtemoc, Cuauhtemoc Chihuahua, Mexico, 31543
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Manufacturer, Repackager or relabeler
First device listed: March 30, 1999
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Bag, Ice	KYR	1	Manufacturer	accessdata.fda.gov
Bag, Intestine	KGY	1	Manufacturer	accessdata.fda.gov
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration	KDH	2	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Manufacturer	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Ent	ERY	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Lumbar Puncture Tray (Adult & Pediatric)	PWY	2	Manufacturer	accessdata.fda.gov
Manometer, Spinal-Fluid	FMJ	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Manufacturer	accessdata.fda.gov
Tourniquet Kit	OJS	1	Manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Manufacturer	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	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
July 29, 2020	K200824	Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown	FYA	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
June 9, 2017	K170762	Cardinal Health Non-Reinforced Surgical Gown	FYA	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
May 21, 2015	K150151	SmartGownTM surgical gown	FYA	Substantially Equivalent	Cardinal Health 200, Inc.	accessdata.fda.gov
June 5, 2006	K061308	TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N	FYA	Substantially Equivalent	Cardinal Health 200, Inc.	accessdata.fda.gov
October 2, 2002	K023167	BREATHABLE SURGICAL GOWN	FYA	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
March 18, 2002	K020593	CONVERTORS SMS POLYOLEFIN GOWN	FYA	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
July 10, 1992	K922468	ANGEL WING SETS -- MODIFIED	GIM	Substantially Equivalent	Mbo Laboratories, Inc.	accessdata.fda.gov
February 18, 1992	K920184	ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.	GIM	Substantially Equivalent	Mbo Laboratories, Inc.	accessdata.fda.gov
October 2, 1991	K912563	ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE	FOZ	Substantially Equivalent	Mbo Laboratories, Inc.	accessdata.fda.gov
August 25, 1982	K822382	U.V.A.C. HANDLER SET	HHK	Substantially Equivalent	American Hospital Supply Corp.	accessdata.fda.gov
March 9, 1977	K770248	ARGYLE RAPID GASTRIC LAVAGE KIT	KDH	Substantially Equivalent	Sherwood Medical Industries	accessdata.fda.gov

Compare with other makers

Updated July 29, 2020. 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.