510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043581Substantially Equivalent

Dual Lumen Catheter

Acmi Corporation, Southborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043581 is the FDA 510(k) clearance record for DUAL LUMEN CATHETER, a class II device, cleared for Acmi Corporation on under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 16 510(k) clearances for Acmi Corporation, from to . As of , FDA records show one recall naming K043581.

Clearance record

Decision date
Received
(65 days to decision)
Product code
EYB Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Acmi Corporation 136 Tpke. Rd., Southborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EYB

Trailing 12 months

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

FDA records show no clearances under product code EYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYB, 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