AFFINITY VENOUS RESERVIOR BAG— 510(k) K935717

Name: FDA 510(k) clearance K935717
Creator: U.S. Food and Drug Administration
Published: 1994-05-10

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K935717 for AFFINITY VENOUS RESERVIOR BAG, Substantially Equivalent on 1994-05-10. Applicant: Avecor Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1993-11-30
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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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.