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, Mexico, 11 510(k) clearances
QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V. is registered with the FDA (registration 8030678) in CUAUHTEMOC, CHIHUAHUA Mexico, Mexico. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 3, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8030678
- FEI number
- 3008373372
- Address
- AVE. RIO STA. CLARA - LOTES 12 y 13 S/N PARQUE INDUSTRIAL CUAUHTEMOC, CUAUHTEMOC, CHIHUAHUA Mexico, Mexico, 31543
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- April 11, 2006
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 3, 2023 | K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | FXX | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| 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 |
| December 2, 2019 | K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | FXX | 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 |
| March 4, 2015 | K142990 | Insta-Gard Surgical and Procedure Face Mask | FXX | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| June 20, 2014 | K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | FXX | Substantially Equivalent | Cardinal Health200, LLC | 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 |
| June 4, 1980 | K801036 | SURGICAL MASK | FXX | Substantially Equivalent | American Threshold Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Mask, Surgical
- All makers of Drape, Surgical, Exempt
- All makers of General Surgery Tray
- All makers of Tray, Surgical, Instrument
- All makers of Drape, Urological, Disposable
Updated July 3, 2023. 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.