Data / Medical devices / Console, Heart-Lung Machine, Cardiopulmonary Bypass
Console, Heart-Lung Machine, Cardiopulmonary Bypass (DTQ): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ, Class 2, 21 CFR 870.4220). 8 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on August 24, 2023, and lists 116 recall events (3 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- DTQ
- Device class
- 2
- Regulation
- 870.4220
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 4 |
| United Kingdom | 1 |
| Italy | 1 |
| India | 1 |
Makers of Console, Heart-Lung Machine, 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 |
|---|---|---|---|---|---|---|---|---|
| LivaNova Deutschland GmbH | MUNCHEN Bavaria, Germany | Manufacturer | 11 | August 24, 2023 | 0 | 4 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer, Manufacturer for export | 8 | April 18, 2023 | 0 | 80 | 0 | api.fda.gov |
| MAQUET CARDIOPULMONARY GmbH | Hechingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 3 | May 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| MAQUET CARDIOPULMONARY GmbH | Rastatt Baden-Wurttemberg, Germany | Specification developer | 2 | May 21, 2014 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | March 21, 2007 | 0 | 1 | 0 | api.fda.gov |
| Spectrum Medical Ltd | GLOUCESTER Gloucestershire, United Kingdom | Manufacturer | 2 | May 24, 2019 | 0 | 2 | 1 | api.fda.gov |
| Century HLM, LLC | Saint Charles, MO, United States | Specification developer | 1 | March 7, 2021 | 0 | 1 | 0 | api.fda.gov |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 1 | November 5, 2009 | 0 | 0 | 0 | api.fda.gov |
| Medikomp GMBH | Rastatt Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediyant Technologies Private Limited | Vadodara Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 24, 2023. 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.