510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994390Substantially Equivalent

Gambro Polyflux 17R, Capillary Dialyzer/ Filter

Gambro Healthcare, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994390 is the FDA 510(k) clearance record for GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER, a class II device, cleared for Gambro Healthcare on under FDA product code MSF (Hemodialyzer, Re-Use, High Flux). FDA records list 13 510(k) clearances for Gambro Healthcare, from to . As of , FDA records show no recalls naming K994390.

Clearance record

Decision date
Received
(303 days to decision)
Product code
MSF Hemodialyzer, Re-Use, High Flux
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Healthcare 1185 Oak St., Lakewood CO
510(k) summary
Summary
Third party review
No

Clearances, product code MSF

Trailing 12 months

FDA records hold no clearances under product code MSF in the trailing twelve months.

FDA records show no clearances under product code MSF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260