Data / Medical devices / Percutaneous Sheath Introducer Kit
Percutaneous Sheath Introducer Kit (OFL): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Percutaneous Sheath Introducer Kit (product code OFL, Class 2, 21 CFR 870.1340). 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 4 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OFL
- Device class
- 2
- Regulation
- 870.1340
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Mexico | 2 |
| China | 1 |
| Costa Rica | 1 |
Makers of Percutaneous Sheath Introducer 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 |
|---|---|---|---|---|---|---|---|---|
| Argon Medical Devices Inc. | Athens, TX, United States | 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 | |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract 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 | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galt Medical Corp. | Garland, TX, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Minnesota Medtec, Inc. | Maple Grove, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theragenics Costa Rica Limitada | El Coyol Alajuela, Costa Rica | Manufacturer | 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.