DeviceClearance

K112587

Substantially Equivalent

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

Applicant
Terumo Cardiovascular Systems Corp.
Product code
DWB
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DWB

product code DWB
Death
2
Total
2

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.