510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042672Substantially Equivalent

14F Dual Floating Dialysis Catheter/tray

Cardio Med Supplies, Inc., Gormley, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042672 is the FDA 510(k) clearance record for 14F DUAL FLOATING DIALYSIS CATHETER/TRAY, a class II device, cleared for Cardio Med Supplies, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 5 510(k) clearances for Cardio Med Supplies, Inc., from to . As of , FDA records show no recalls naming K042672.

Clearance record

Decision date
Received
(175 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cardio Med Supplies, Inc. 5 Gormley Industrial Ave., Gormley, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

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