DeviceClearance

K831849

Substantially Equivalent

PLEURAL DRAINAGE SYS #PDS-100-4

Applicant
American Bentley
Product code
CAC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC
Death
11
Malfunction
477
Total
488

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.