DeviceClearance

K884564

Substantially Equivalent

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM

Applicant
Shiley, Inc.
Product code
CAC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, 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.