Data / Medical devices / Pump, Blood, Cardiopulmonary Bypass, Roller Type
Pump, Blood, Cardiopulmonary Bypass, Roller Type (DWB): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB, Class 2, 21 CFR 870.4370). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on November 17, 2016, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWB
- Device class
- 2
- Regulation
- 870.4370
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| India | 1 |
Makers of Pump, Blood, Cardiopulmonary Bypass, Roller Type
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 Systems Corporation | Ann Arbor, MI, United States | Complaint file establishment, Manufacturer | 4 | November 17, 2016 | 0 | 2 | 0 | api.fda.gov |
| Century HLM, LLC | Saint Charles, MO, United States | Specification developer | 1 | July 14, 1997 | 0 | 0 | 0 | api.fda.gov |
| Mediyant Technologies Private Limited | Vadodara Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 17, 2016. 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.