Gambro Polyflux 17R, Capillary Dialyzer/ Filter

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K994390 ↗

FDA Product Code

MSF

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Gambro Healthcare →