DeviceClearance

K000704

Substantially Equivalent

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

Applicant
Dmc Medical, Ltd.
Product code
GBX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fullerton, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GBX

product code GBX
Death
16
Injury
583
Malfunction
3,578
Other
1
Total
4,178

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.