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
K831401Substantially Equivalent

Single Needle Subclavian Vein Access

Med-West, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831401 is the FDA 510(k) clearance record for SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS, a class II device, cleared for Med-West, Inc. on under FDA product code FIQ (Cannula, A-V Shunt). FDA records list 11 510(k) clearances for Med-West, Inc., from to . As of , FDA records show no recalls naming K831401.

Clearance record

Decision date
Received
(32 days to decision)
Product code
FIQ Cannula, A-V Shunt
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Med-West, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FIQ

Trailing 12 months

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

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