EXPRESS AND OASIS CHEST DRAIN— 510(k) K043140

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K043140 for EXPRESS AND OASIS CHEST DRAIN, Substantially Equivalent on 2004-12-08. Applicant: Atrium Medical Corp..

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2004-11-15
Decision date: 2004-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.