K233499

Substantially Equivalent

Sapphire NC ULTRA Coronary Dilatation Catheter

Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code: LOX
Advisory panel: Cardiovascular
Date received: 2023-10-31
Decision date: 2024-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.