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
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K120674Unknown

Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter

Medtronic, Inc., Mansfield MA / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120674 is the FDA 510(k) clearance record for MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER, a class II device, cleared for Covidien on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 2 recalls naming K120674.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPB

Trailing 12 months

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

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