Data / Medical devices / Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Sucker, Cardiotomy Return, Cardiopulmonary Bypass (DTS): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Sucker, Cardiotomy Return, Cardiopulmonary Bypass (product code DTS, Class 2, 21 CFR 870.4420). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on January 26, 2006, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTS
- Device class
- 2
- Regulation
- 870.4420
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 2 |
| Mexico | 1 |
| Italy | 1 |
| Pakistan | 1 |
| United Kingdom | 1 |
Makers of Sucker, Cardiotomy Return, 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 USA, INC. | Arvada, CO, United States | Manufacturer | 1 | September 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer | 1 | October 2, 1979 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 1 | October 2, 1979 | 0 | 0 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Specification developer | 1 | June 30, 1980 | 0 | 0 | 0 | api.fda.gov |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 1 | March 28, 1990 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HMT Medizintechnik GmbH | Maisach Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pemco, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMT Schilling Metalltechnik GMBH | MUHLHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Temed | Sidlesham West Sussex, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 26, 2006. 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.