510(k) K831849— PLEURAL DRAINAGE SYS #PDS-100-4

Substantially Equivalent

American Bentley

Clearance details

Applicant: American Bentley
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1983-06-08
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.