K935717

Substantially Equivalent

AFFINITY VENOUS RESERVIOR BAG

Applicant: Avecor Cardiovascular, Inc.
Product code: DTN
Advisory panel: Cardiovascular
Date received: 1993-11-30
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.