JADE— 510(k) K202231

Name: FDA 510(k) clearance K202231
Creator: U.S. Food and Drug Administration
Published: 2020-12-10

Substantially Equivalent

OrbusNeich Medical (Shenzhen) Co., Ltd.

FDA 510(k) clearance K202231 for JADE, Substantially Equivalent on 2020-12-10. Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.. Device class: 2.

Clearance details

Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2020-08-07
Decision date: 2020-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.