K252122

Substantially Equivalent

DCwire Micro-guidewire

Applicant: Shanghai Achieva Medical Suzhou Co., Ltd.
Product code: MOF
Advisory panel: Cardiovascular
Date received: 2025-07-07
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.