Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)— 510(k) K251185

Substantially Equivalent

Intervene

FDA 510(k) clearance K251185 for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020), Substantially Equivalent on 2025-10-22. Applicant: Intervene.

Clearance details

Applicant: Intervene
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2025-04-16
Decision date: 2025-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.