K241207

Substantially Equivalent

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

Applicant
Devoro Medical, Inc.
Product code
QEW
Advisory panel
Cardiovascular
Date received
Decision date
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, through . 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.