K030398

Substantially Equivalent

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

Applicant: Cardiacassist, Inc.
Product code: DQR
Advisory panel: Cardiovascular
Date received: 2003-02-06
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.