510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030538Substantially Equivalent

American Catheter, Model W3

Catheter, LLC, Winsted CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030538 is the FDA 510(k) clearance record for AMERICAN CATHETER, MODEL W3, a class II device, cleared for Catheter, LLC on under FDA product code EZD (Catheter, Straight). FDA records list one 510(k) clearance for Catheter, LLC. As of , FDA records show no recalls naming K030538.

Clearance record

Decision date
Received
(18 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Catheter, LLC 106 Groppo Dr., Winsted CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260