SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)— 510(k) K241207

Substantially Equivalent

Devoro Medical, Inc.

FDA 510(k) clearance K241207 for SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02), Substantially Equivalent on 2024-05-29. Applicant: Devoro Medical, Inc..

Clearance details

Applicant: Devoro Medical, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2024-04-30
Decision date: 2024-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, 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.