Data / Medical devices / Filter, Blood, Cardiopulmonary Bypass, Arterial Line / United States
FDA-registered makers of Filter, Blood, Cardiopulmonary Bypass, Arterial Line in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Product code
- DTM
- Country
- United States
Makers of Filter, Blood, Cardiopulmonary Bypass, Arterial Line in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 5 | January 16, 2026 | 0 | 2 | 0 | api.fda.gov |
| Enablecv, LLC | Midvale, UT, United States | Specification developer | 3 | September 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | March 15, 1982 | 0 | 0 | 0 | api.fda.gov |
| Transmedics, Inc. | Andover, MA, United States | Manufacturer | 1 | October 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 0 | 0 | 1 | 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.