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
K955002Substantially Equivalent

Mahurkar 8 Fr Dual Lemen Catheter

Quinton, Inc., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955002 is the FDA 510(k) clearance record for MAHURKAR 8 FR DUAL LEMEN CATHETER, a class II device, cleared for Quinton, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K955002.

Clearance record

Decision date
Received
(317 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Quinton, Inc. 3303 Monte Villa Pkwy., Bothell WA
510(k) summary
Summary
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