Data / Medical devices / Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass (DTW): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW, Class 2, 21 CFR 870.4340). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on May 8, 2015, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTW
- Device class
- 2
- Regulation
- 870.4340
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
Makers of Monitor And/Or Control, Level Sensing, 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 |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | September 30, 1987 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | September 30, 1987 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer | 1 | May 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| Apmtd, Inc. | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov |
Updated May 8, 2015. 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.