DeviceClearance

K830840

Substantially Equivalent

OPEN ENDED URETERAL CATHETER

Applicant
Van-Tec, Inc.
Product code
GBM
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM
Injury
397
Malfunction
1,404
Total
1,801

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.