Data / Medical devices / Mexico / Cirpro de Delicias S. de R.L. de C.V.
Cirpro de Delicias S. de R.L. de C.V.: FDA-registered device maker in DELICIAS Chihuahua, Mexico, 8 510(k) clearances
Cirpro de Delicias S. de R.L. de C.V. is registered with the FDA (registration 8030672) in DELICIAS Chihuahua, Mexico. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030672
- FEI number
- 3194
- Address
- Calle Parque Industrial Las Virgenes S/N Colonia Parque Industrial Las Virgenes, DELICIAS Chihuahua, Mexico, 33018
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- May 23, 1994
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 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 |
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 27, 2023 | K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | FYA | Substantially Equivalent | Cardinal Health200, LLC | 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 |
| 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 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 |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Drape, Surgical, Exempt
- All makers of Mask, Surgical
- All makers of General Surgery Tray
Updated July 27, 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.