KENZ CARDY302 MAX— 510(k) K101024

Name: FDA 510(k) clearance K101024
Creator: U.S. Food and Drug Administration
Published: 2011-01-06

Substantially Equivalent

Suzuken Co., Ltd.

FDA 510(k) clearance K101024 for KENZ CARDY302 MAX, Substantially Equivalent on 2011-01-06. Applicant: Suzuken Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzuken Co., Ltd.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2010-04-13
Decision date: 2011-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.