Data / Medical devices / Reservoir, Blood, Cardiopulmonary Bypass / United States
FDA-registered makers of Reservoir, Blood, Cardiopulmonary Bypass in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Reservoir, Blood, Cardiopulmonary Bypass (product code DTN). 4 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Reservoir, Blood, Cardiopulmonary Bypass
- Product code
- DTN
- Country
- United States
Makers of Reservoir, Blood, Cardiopulmonary Bypass 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 | 11 | May 27, 2015 | 0 | 4 | 1 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | December 2, 2015 | 0 | 1 | 0 | api.fda.gov |
| Global Blood Resources, LLC | Windsor, CT, United States | Specification developer | 1 | June 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 1 | October 1, 1992 | 0 | 2 | 0 | api.fda.gov |
| Kluge Design Inc. | Rogers, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract 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.