K232480

Substantially Equivalent

ProtekDuo Veno-Venous Cannula Sets

Applicant
Cardiacassist, Inc.
Product code
PZS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pittsburg, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PZS

product code PZS
Death
17
Total
17

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.