510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944007Substantially Equivalent

Europhilic Slippery Coated Foley Catheter

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

K944007 is the FDA 510(k) clearance record for EUROPHILIC SLIPPERY COATED FOLEY CATHETER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K944007.

Clearance record

Decision date
Received
(317 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 27636 Ave. Scott, Velencia CA
510(k) summary
Statement
Third party review
No

Clearances, product code EZL

Trailing 12 months
4 clearances under product code EZL 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 EZL, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20261
November 20260