510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832324Substantially Equivalent

Thermal Dilution Catheter

Catheter Corp. of America, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832324 is the FDA 510(k) clearance record for THERMAL DILUTION CATHETER, a class II device, cleared for Catheter Corp. of America on under FDA product code DYG (Catheter, Flow Directed). FDA records list one 510(k) clearance for Catheter Corp. of America. As of , FDA records show no recalls naming K832324.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Catheter Corp. of America 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DYG

Trailing 12 months

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

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