COSEAL— 510(k) K131411

Substantially Equivalent

Jilin Coronado Medical , Ltd.

FDA 510(k) clearance K131411 for COSEAL, Substantially Equivalent on 2013-09-26. Applicant: Jilin Coronado Medical , Ltd..

Clearance details

Applicant: Jilin Coronado Medical , Ltd.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2013-05-15
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jilin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.