510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863218Substantially Equivalent

Cytostatic Filtration Set

Meadox Surgimed, Inc., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863218 is the FDA 510(k) clearance record for CYTOSTATIC FILTRATION SET, a class II device, cleared for Meadox Surgimed, Inc. on under FDA product code LFK (Catheter, Femoral). FDA records list 24 510(k) clearances for Meadox Surgimed, Inc., from to . As of , FDA records show no recalls naming K863218.

Clearance record

Decision date
Received
(176 days to decision)
Product code
LFK Catheter, Femoral
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Meadox Surgimed, Inc. 112 Bauer Dr., Oakland NJ
Third party review
No

Clearances, product code LFK

Trailing 12 months

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

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