COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)— 510(k) K242588

Substantially Equivalent

OrbusNeich Medical (Shenzhen) Co., Ltd.

FDA 510(k) clearance K242588 for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL), Substantially Equivalent on 2025-01-07. Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd..

Clearance details

Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2024-08-30
Decision date: 2025-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.