Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface— 510(k) K142784

Name: FDA 510(k) clearance K142784
Creator: U.S. Food and Drug Administration
Published: 2014-10-24

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K142784 for Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface, Substantially Equivalent on 2014-10-24. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DTZ
Device class: Class 2
Regulation: 21 CFR 870.4350
Advisory panel: Cardiovascular
Date received: 2014-09-26
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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 →

Recalls naming K142784

K-number listed on FDA's recall record

Z-0826-2017 — Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Class II·Terminated·Medtronic Inc·20161116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142784.

Data sourced from openFDA. This site is unofficial and independent of the FDA.