Data / Medical devices / Cardiac Catheterization Kit
Cardiac Catheterization Kit (OES): 19 FDA-registered makers in 5 countries
19 establishments in 5 countries are registered with the FDA to make Cardiac Catheterization Kit (product code OES, Class 2, 21 CFR 870.1200). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 52 recall events (8 Class I). FDA data exported November 2, 2026.
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- Product code
- OES
- Device class
- 2
- Regulation
- 870.1200
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 7 |
| Ireland | 1 |
| China | 1 |
| Honduras | 1 |
Makers of Cardiac Catheterization Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 6 | 3 | api.fda.gov | |
| ArcRoyal uc | Kells Meath, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | Chelmsford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - SPT | Waukegan, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packroom LLC | Mc Donough, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.