ICHOR 7F Embolectomy System (ICH-7F)— 510(k) K233917

Substantially Equivalent

Ichor

FDA 510(k) clearance K233917 for ICHOR 7F Embolectomy System (ICH-7F), Substantially Equivalent on 2024-07-18. Applicant: Ichor.

Clearance details

Applicant: Ichor
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2023-12-12
Decision date: 2024-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.