510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934803Substantially Equivalent

Arterial & Venous Blood Tubing Sets for Hemodialysis

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934803 is the FDA 510(k) clearance record for ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K934803.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 1620 Waulkegan Rd., Mcgaw Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code FJK

Trailing 12 months
2 clearances under product code FJK in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FJK, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260