510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023368Substantially Equivalent

Trucath.ip

Aortech Critical Care, Ltd., Bellshill, Lanarkshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023368 is the FDA 510(k) clearance record for TRUCATH.IP, a class II device, cleared for Aortech Critical Care , Ltd. on under FDA product code DFG (Lambda, Rhodamine, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Aortech Critical Care , Ltd. As of , FDA records show no recalls naming K023368.

Clearance record

Decision date
Received
(20 days to decision)
Product code
DFG Lambda, Rhodamine, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Aortech Critical Care , Ltd. Phoenix Crescent,, Bellshill, Lanarkshire, GB
510(k) summary
Statement
Third party review
No

Clearances, product code DFG

Trailing 12 months

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

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