510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970681Substantially Equivalent

Altra Nova 200 Hemodialyzer

Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970681 is the FDA 510(k) clearance record for ALTRA NOVA 200 HEMODIALYZER, a class II device, cleared for Althin Medical AB an Affiliate of Baxter Intl on under FDA product code MSF (Hemodialyzer, Re-Use, High Flux). FDA records list 27 510(k) clearances for Althin Medical AB an Affiliate of Baxter Intl, from to . As of , FDA records show no recalls naming K970681.

Clearance record

Decision date
Received
(514 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
Althin Medical AB an Affiliate of Baxter Intl 14620 NW 60th Ave., Miami Lakes FL
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