510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844433Substantially Equivalent

Vaccess 2000 Single Lumen Subclavian Cannula

Vas-Cath of Canada, Ltd., Ontario, L5a 3v3, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844433 is the FDA 510(k) clearance record for VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA, a class II device, cleared for Vas-Cath of Canada , Ltd. on under FDA product code LFJ (Catheter, Subclavian). FDA records list 19 510(k) clearances for Vas-Cath of Canada , Ltd., from to . As of , FDA records show one recall naming K844433.

Clearance record

Decision date
Received
(117 days to decision)
Product code
LFJ Catheter, Subclavian
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vas-Cath of Canada , Ltd. 2380 Tedlo St. Mississauga, Ontario, L5a 3v3, CA
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFJ, 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