COLIGN— 510(k) K131124

Substantially Equivalent

Jilin Coronado Medical , Ltd.

FDA 510(k) clearance K131124 for COLIGN, Substantially Equivalent on 2013-08-28. Applicant: Jilin Coronado Medical , Ltd..

Clearance details

Applicant: Jilin Coronado Medical , Ltd.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2013-04-22
Decision date: 2013-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jilin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.