THORA-KLEX CHEST DRAINAGE UNIT— 510(k) K896127

Name: FDA 510(k) clearance K896127
Creator: U.S. Food and Drug Administration
Published: 1990-01-24

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K896127 for THORA-KLEX CHEST DRAINAGE UNIT, Substantially Equivalent on 1990-01-24. Applicant: Davol, Inc.. Device class: 2.

Clearance details

Applicant: Davol, Inc.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1989-10-23
Decision date: 1990-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

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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.