510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926450Substantially Equivalent

Edslab(r) Dual Lumen Region Satur Oximetry Cath

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926450 is the FDA 510(k) clearance record for EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DQE (Catheter, Oximeter, Fiber-Optic). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K926450.

Clearance record

Decision date
Received
(60 days to decision)
Product code
DQE Catheter, Oximeter, Fiber-Optic
Regulation
21 CFR 870.1230
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
510(k) summary
Statement
Third party review
No

Clearances, product code DQE

Trailing 12 months

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

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