Data / Medical devices / Catheter, Umbilical Artery
Catheter, Umbilical Artery (FOS): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Catheter, Umbilical Artery (product code FOS, Class 2, 21 CFR 880.5200). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on May 6, 2021, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- FOS
- Device class
- 2
- Regulation
- 880.5200
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 3 |
| Costa Rica | 1 |
| Portugal | 1 |
| Belgium | 1 |
| China | 1 |
Makers of Catheter, Umbilical Artery
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 6 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health Costa Rica, S.A. | -- Alajuela, Costa Rica | Manufacturer | 6 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer, Specification developer | 4 | October 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Footprint Medical Inc. | San Antonio, TX, United States | Manufacturer | 3 | March 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 3 | August 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Vygon Portugal | Balter-Paredes Porto, Portugal | Manufacturer | 2 | October 26, 1992 | 0 | 0 | 0 | api.fda.gov |
| Dimequip | Frameries Hainaut, Belgium | Manufacturer | 1 | October 26, 1992 | 0 | 0 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 1 | May 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Haolang Medical Usa Corporation | Clyde Hill, WA, United States | Specification developer | 1 | May 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sipa | Avesnes Sur Helpe Hauts-de-France, France | Manufacturer | 1 | October 26, 1992 | 0 | 0 | 0 | api.fda.gov |
| Sipv | Ecouen Ile-de-France, France | Manufacturer | 1 | October 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Haolang Technology (foshan) Limited Corporation | Foshan Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 6, 2021. 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.