510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K203409Substantially Equivalent

MC3 Crescent Jugular Dual Lumen Catheter

MC3, Inc., Dexter MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203409 is the FDA 510(k) clearance record for MC3 Crescent Jugular Dual Lumen Catheter, a class II device, cleared for Mc3, Inc. on under FDA product code PZS (Dual Lumen Ecmo Cannula). FDA's definition for product code PZS reads: "Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent". FDA records list 2 510(k) clearances for Mc3, Inc., from to . As of , FDA records show no recalls naming K203409.

Clearance record

Decision date
Received
(165 days to decision)
Product code
PZS Dual Lumen Ecmo Cannula
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Mc3, Inc. 2555 Bishop Cir. W, Dexter MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZS

Trailing 12 months

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

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