ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN— 510(k) K950677

Name: FDA 510(k) clearance K950677
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K950677 for ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN, Substantially Equivalent on 1995-04-13. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1995-02-14
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, 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.