K232542

Substantially Equivalent

Wedge XL Delivery Catheter

Applicant
MicroVention, Inc.
Product code
QJP
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Aliso Viejo, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code QJP

product code QJP
Death
43
Injury
233
Malfunction
1,010
Total
1,286

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.