Data / Medical devices / Microfilter, Blood Transfusion
Microfilter, Blood Transfusion (CAK): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Microfilter, Blood Transfusion (product code CAK, Class 2, 21 CFR 880.5440). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on May 17, 2006, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CAK
- Device class
- 2
- Regulation
- 880.5440
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 2 |
| France | 2 |
| Dominican Republic | 1 |
Makers of Microfilter, Blood Transfusion
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 |
|---|---|---|---|---|---|---|---|---|
| GVS TM, Inc. | Covina, CA, United States | Manufacturer | 3 | April 22, 1996 | 0 | 1 | 0 | api.fda.gov |
| GVS Filter Technology De Mexico | Apodaca N.L Nuevo Leon, Mexico | Manufacturer | 2 | April 22, 1996 | 0 | 0 | 0 | api.fda.gov |
| Charter Medical, LLC | Winston Salem, NC, United States | Manufacturer | 1 | August 30, 1999 | 0 | 0 | 0 | api.fda.gov |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | October 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 1 | October 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maco Pharma | MOUVAUX Hauts-de-France, France | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Macoproductions S.A.S. | TOURCOING Nord, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 17, 2006. 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.