DeviceClearance

K232578

Substantially Equivalent

VASSALLO GT 018 G12; VASSALLO GT 018 G30

Applicant
Filmec Co. , Ltd.
Product code
DQX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hagoya-Shi, JP
Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX
Death
298
Injury
4,385
Malfunction
7,203
Other
5
Total
11,891

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.