510(k) K234065 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
CDI OneView Monitoring System
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 25, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2025 | Terumo Cardiovascular Systems Corporation CDI OneView System BPM Probe:
Cat. No. CDI753 - CDI OneView BPM Probe,
Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit Open, Classified |
DRY | None listed |
| Mar 31, 2025 | Terumo Cardiovascular Systems Corporation Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 Open, Classified |
DRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.