Data / Medical devices / Reservoir, Blood, Cardiopulmonary Bypass
Reservoir, Blood, Cardiopulmonary Bypass (DTN): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Reservoir, Blood, Cardiopulmonary Bypass (product code DTN, Class 2, 21 CFR 870.4400). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 169 510(k) clearances under this code, the latest on December 22, 2025, and lists 15 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- DTN
- Device class
- 2
- Regulation
- 870.4400
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Italy | 3 |
| Mexico | 2 |
| Japan | 1 |
| Dominican Republic | 1 |
| Slovenia | 1 |
Makers of Reservoir, Blood, 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 | 11 | May 27, 2015 | 0 | 4 | 1 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 7 | May 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 7 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | December 2, 2015 | 0 | 1 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | February 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | June 29, 1999 | 0 | 0 | 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 |
| Spectrum Medical SRL | Mirandola Modena, Italy | Manufacturer | 1 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bioprod D.O.O. | Ljubljana, Slovenia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurosets s.r.l. | Medolla Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 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 December 22, 2025. 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.