510(k) K200109 ยท DTZ Oxygenator, Cardiopulmonary Bypass
OXY-1 System
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Oct 23, 2020 |
| Received | Jan 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2022 | Abiomed, Inc. OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.
OXY-1 System consists of Console, Pump Drive,
E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.