510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965178Substantially Equivalent

Niagara Dual Lumen Catheter

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

K965178 is the FDA 510(k) clearance record for NIAGARA DUAL LUMEN CATHETER, a class II device, cleared for Vas-Cath, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 27 510(k) clearances for Vas-Cath, Inc., from to . As of , FDA records show no recalls naming K965178.

Clearance record

Decision date
Received
(238 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vas-Cath, Inc. 2380 Tedlo St. Mississauga, Ontario, L5a 3v3, CA
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