K043582

Substantially Equivalent

OCEAN CHEST DRAIN

Applicant: Atrium Medical Corp.
Product code: KDQ
Advisory panel: General Hospital
Date received: 2004-12-28
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

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.