DeviceClearance

K201305

Substantially Equivalent

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

Applicant
Atrium Medical Corporation
Product code
CAC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Merrimack, 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, through . 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.