DeviceClearance

K181828

Substantially Equivalent

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile

Applicant
Scientia Vascular, LLC
Product code
MOF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Valley City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MOF

product code MOF
Death
6
Injury
137
Total
143

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.