THERMAL DILUTION CATHETER— 510(k) K823484

Name: FDA 510(k) clearance K823484
Creator: U.S. Food and Drug Administration
Published: 1982-12-22

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K823484 for THERMAL DILUTION CATHETER, Substantially Equivalent on 1982-12-22. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DYG
Device class: Class 2
Regulation: 21 CFR 870.1240
Advisory panel: Cardiovascular
Date received: 1982-11-23
Decision date: 1982-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYG

view all

More clearances from Instrumentation Laboratory CO

view all

K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
K223187 — HemosIL Liquid Anti-Xa2023-06-23
K223090 — GEM Premier ChemSTAT2023-01-27
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
K213464 — HemosIL Liquid Anti-Xa2022-10-04

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.