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510(k) K253838

Lifemotion Disposable Membrane Oxygenator by Lifemotion Medical Technology Co., Ltd. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2026
Date Received
December 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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