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
K020089Substantially Equivalent

Mahurkar Triple Lumen Catheter, 12 Fr

Kendall, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020089 is the FDA 510(k) clearance record for MAHURKAR TRIPLE LUMEN CATHETER, 12 FR, a class II device, cleared for The Kendall Company on under FDA product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted). FDA's definition for product code NIE reads: "Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion". FDA records list 22 510(k) clearances for The Kendall Company, from to . As of , FDA records show 26 recalls naming K020089.

Clearance record

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

Clearances, product code NIE

Trailing 12 months

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

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