PLEURAL DRAINAGE SYSTEM #PDS-4300— 510(k) K812224

Substantially Equivalent

Bentley Laboratories, Inc.

FDA 510(k) clearance K812224 for PLEURAL DRAINAGE SYSTEM #PDS-4300, Substantially Equivalent on 1981-09-09. Applicant: Bentley Laboratories, Inc..

Clearance details

Applicant: Bentley Laboratories, Inc.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1981-08-10
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.