DeviceClearance

K854773

Substantially Equivalent

SUPERCATH A.V. FISTULA

Applicant
Togo Medikit Co., Ltd.
Product code
FIE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chiyoda-Ku Tokyo101 Japan, JP
Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE
Death
2
Total
2

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.