DeviceClearance

K231148

Substantially Equivalent

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm

Applicant
Vvt Medical , Ltd.
Product code
KRA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kfar Saba, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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.