510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905080Substantially Equivalent

Med-West Dual Lumen Internal Jugular Catheter

Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905080 is the FDA 510(k) clearance record for MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER, a class II device, cleared for Kendall Healthcare Products Co. Div.Of Tyco Health on under FDA product code LFJ (Catheter, Subclavian). FDA records list 66 510(k) clearances for Kendall Healthcare Products Co. Div.Of Tyco Health, from to . As of , FDA records show no recalls naming K905080.

Clearance record

Decision date
Received
(79 days to decision)
Product code
LFJ Catheter, Subclavian
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health 15 Hampshire St., Mansfield MA
Third party review
No

Clearances, product code LFJ

Trailing 12 months

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

FDA records show no clearances under product code LFJ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260