510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861543Substantially Equivalent

Cardiomax-II

Columbus Instruments Intl. Corp., Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861543 is the FDA 510(k) clearance record for CARDIOMAX-II, a class II device, cleared for Columbus Instruments Intl. Corp. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 5 510(k) clearances for Columbus Instruments Intl. Corp., from to . As of , FDA records show no recalls naming K861543.

Clearance record

Decision date
Received
(320 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Columbus Instruments Intl. Corp. P.O. Box 44049, Columbus OH
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260