510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820859Substantially Equivalent

Coaxial Dual Flow Catheter

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820859 is the FDA 510(k) clearance record for COAXIAL DUAL FLOW CATHETER, a class II device, cleared for Terumo Medical Corp. on under FDA product code LBW (Set, Dialysis, Single Needle (Co-Axial Flow)). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K820859.

Clearance record

Decision date
Received
(18 days to decision)
Product code
LBW Set, Dialysis, Single Needle (Co-Axial Flow)
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code LBW

Trailing 12 months

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

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