T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES— 510(k) K861025

Substantially Equivalent

Boehringer Laboratories

FDA 510(k) clearance K861025 for T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES, Substantially Equivalent on 1986-04-28. Applicant: Boehringer Laboratories.

Clearance details

Applicant: Boehringer Laboratories
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1986-03-18
Decision date: 1986-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.