DeviceClearance

K953741

Substantially Equivalent

THERMACYL BLOOD/FLUID WARMER

Applicant
Baxter Healthcare Corp
Product code
BSB
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Round Lake, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BSB

product code BSB
Death
5
Malfunction
1,778
Total
1,783

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.