AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE— 510(k) K132972

Clearance details

Applicant

Medtronic, Inc.

Product code

Code DTN

Device class

Class 2

Regulation

21 CFR 870.4400

Advisory panel

Cardiovascular

Date received

2013-09-23

Decision date

2013-10-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Minneapolis, MN, US

• K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
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• K223361 — BMR 1900 PHISIO2023-06-10
• K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

• K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
• K262005 — Affera Integrated Mapping System2026-08-21
• K261335 — VitalFlow Set with Balance Biosurface2026-07-31
• K261866 — Concerto Versa Detachable Coil2026-06-24
• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

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 →

• 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
• Z-0531-2015 — The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.Class II·Terminated·Medtronic Perfusion Systems·20141031

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132972.