DeviceClearance

K893188

Substantially Equivalent

QUINTON SINGLE LUMEN CATHETER

Applicant
Quinton, Inc.
Product code
MPB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bothell, WA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MPB

product code MPB
Death
18
Malfunction
1,042
Total
1,060

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.