CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN— 510(k) K030524

Name: FDA 510(k) clearance K030524
Creator: U.S. Food and Drug Administration
Published: 2003-03-03

Substantially Equivalent

Cd Leycom BV

FDA 510(k) clearance K030524 for CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN, Substantially Equivalent on 2003-03-03. Applicant: Cd Leycom BV. Device class: 2.

Clearance details

Applicant: Cd Leycom BV
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2003-02-19
Decision date: 2003-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Zoetermeer, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.