Data / Medical devices / United States / Breethe, Inc.
Breethe, Inc.: FDA-registered device maker in Halethorpe, MD, United States, 1 510(k) clearance
Breethe, Inc. is registered with the FDA (registration 3014990448) in Halethorpe, MD, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014990448
- Address
- 1500 Joh Ave #190, Halethorpe, MD, United States, 21227
- Owner or operator
- ABIOMED, INC. (1220648)
- Roles
- Manufacturer
- First device listed
- April 20, 2023
- Registered through
- 2026
- Brand names listed
- OXY-1 System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2023 | K223161 | OXY-1 System | DTZ | Substantially Equivalent | Abiomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Updated February 23, 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.