Kenz Cardico1211— 510(k) K172068

Substantially Equivalent

Suzuken Co., Ltd.

FDA 510(k) clearance K172068 for Kenz Cardico1211, Substantially Equivalent on 2018-06-01. Applicant: Suzuken Co., Ltd..

Clearance details

Applicant: Suzuken Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2017-07-07
Decision date: 2018-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.