Data / Medical devices / Venous Ulcer Kit
Venous Ulcer Kit (PYK): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Venous Ulcer Kit (product code PYK, Class 1, 21 CFR 878.4014). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PYK
- Device class
- 1
- Regulation
- 878.4014
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Germany | 1 |
| Mexico | 1 |
| Czechia | 1 |
Makers of Venous Ulcer 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 |
|---|---|---|---|---|---|---|---|---|
| BSN Medical GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 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 | |
| Lohmann & Rauscher s.r.o. | Nová Paka Jicin, Czechia | Contract manufacturer, 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.