K253838
- 510(k) number
- K253838
- Device name
- Lifemotion Disposable Membrane Oxygenator
- Applicant
- Lifemotion Medical Technology Co., Ltd. CN
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2026-03-16
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253838.pdf
Official FDA record: K253838
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.