Data / Medical devices / Tubing, Pump, Cardiopulmonary Bypass
Tubing, Pump, Cardiopulmonary Bypass (DWE): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Tubing, Pump, Cardiopulmonary Bypass (product code DWE, Class 2, 21 CFR 870.4390). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on August 8, 2024, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWE
- Device class
- 2
- Regulation
- 870.4390
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Costa Rica | 1 |
| Mexico | 1 |
Makers of Tubing, Pump, 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 |
|---|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Costa Rica LLC | Zona Franca La Lima Cartago, Costa Rica | Manufacturer | 3 | May 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 2 | August 8, 2024 | 0 | 3 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | January 13, 1981 | 0 | 6 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 2 | January 13, 1981 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 1 | December 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 1 | December 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 1 | September 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 8, 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.