Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030264 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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