ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN— 510(k) K984496

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K984496 for ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN, Substantially Equivalent on 1999-05-05. Applicant: Atrium Medical Corp..

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1998-12-17
Decision date: 1999-05-05
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.