Data / Medical devices / Filter, Intravascular, Cardiovascular
Filter, Intravascular, Cardiovascular (DTK): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Filter, Intravascular, Cardiovascular (product code DTK, Class 2, 21 CFR 870.3375). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 83 510(k) clearances under this code, the latest on September 10, 2024, and lists 13 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- DTK
- Device class
- 2
- Regulation
- 870.3375
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| France | 2 |
| Denmark | 1 |
| Mexico | 1 |
Makers of Filter, Intravascular, Cardiovascular
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 |
|---|---|---|---|---|---|---|---|---|
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 5 | July 22, 2016 | 1 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Specification developer | 3 | April 16, 2015 | 0 | 2 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 3 | March 7, 2014 | 0 | 2 | 1 | api.fda.gov |
| Aln S.A.R.L. | BORMES LES MIMOSAS Var, France | Manufacturer | 2 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical | CHASSENEUIL-DU-POITOU Vienne, France | Manufacturer | 2 | July 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 2 | February 29, 2024 | 0 | 3 | 0 | api.fda.gov |
| William Cook Europe Aps | BJAEVERSKOV Sjaelland, Denmark | Complaint file establishment, Manufacturer | 1 | January 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 2024. 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.