Data / Medical devices / Control, Pump Speed, Cardiopulmonary Bypass
Control, Pump Speed, Cardiopulmonary Bypass (DWA): 14 FDA-registered makers in 8 countries
14 establishments in 8 countries are registered with the FDA to make Control, Pump Speed, Cardiopulmonary Bypass (product code DWA, Class 2, 21 CFR 870.4380). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on May 24, 2024, and lists 10 recall events (3 Class I). FDA data exported November 2, 2026.
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- Product code
- DWA
- Device class
- 2
- Regulation
- 870.4380
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 1 |
| Israel | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
| Japan | 1 |
| Mexico | 1 |
| Malaysia | 1 |
Makers of Control, Pump Speed, 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 | 4 | May 7, 2008 | 0 | 2 | 1 | api.fda.gov |
| LivaNova Deutschland GmbH | MUNCHEN Bavaria, Germany | Manufacturer | 3 | September 20, 2011 | 0 | 5 | 0 | api.fda.gov |
| Apmtd, Inc. | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 2 | April 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| QTREX Quantum Ltd | Ra'anana Central, Israel | Manufacturer | 1 | May 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Medical Ltd | GLOUCESTER Gloucestershire, United Kingdom | Manufacturer | 1 | April 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer, Manufacturer for export | 1 | November 17, 1995 | 0 | 0 | 0 | api.fda.gov |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 1 | August 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Thoratec Corporation | San Ramon, CA, United States | Manufacturer | 1 | August 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Thoratec Switzerland GMBH | Zurich, Switzerland | Manufacturer | 1 | August 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Breethe, Inc. | Halethorpe, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KYOCERA Medical Corporation Shiga Yasu Plant | Yasu-shi Shiga, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 24, 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.