Data / Medical devices / Heat-Exchanger, Cardiopulmonary Bypass
Heat-Exchanger, Cardiopulmonary Bypass (DTR): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Heat-Exchanger, Cardiopulmonary Bypass (product code DTR, Class 2, 21 CFR 870.4240). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 91 510(k) clearances under this code, the latest on March 12, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTR
- Device class
- 2
- Regulation
- 870.4240
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Italy | 3 |
| United Kingdom | 2 |
| Mexico | 1 |
| Japan | 1 |
| Costa Rica | 1 |
| Germany | 1 |
Makers of Heat-Exchanger, Cardiopulmonary Bypass
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 5 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 5 | November 20, 2020 | 0 | 3 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 4 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Medical SRL | Mirandola Modena, Italy | Manufacturer | 3 | March 12, 2026 | 0 | 1 | 0 | api.fda.gov |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 2 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | June 23, 1999 | 0 | 0 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer | 1 | January 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Medical Ltd | GLOUCESTER Gloucestershire, United Kingdom | Manufacturer | 1 | July 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Costa Rica LLC | Zona Franca La Lima Cartago, Costa Rica | Manufacturer | 1 | March 23, 2001 | 0 | 0 | 0 | api.fda.gov |
| Chalice Medical Ltd | Worksop Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurosets s.r.l. | Medolla Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MAQUET CARDIOPULMONARY GmbH | Hechingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 12, 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.