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

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..

Clearance details

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