FDA 510(k)

Affinity Fusion™ Oxygenator System

K-Number: K230640 · 2023-04-06

Decision Date2023-04-06

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Affinity Fusion™ Oxygenator System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K230640. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affinity Fusion™ Oxygenator System?

Affinity Fusion™ Oxygenator System is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Medtronic, Inc.. The 510(k) number is K230640.

When did Affinity Fusion™ Oxygenator System receive FDA 510(k) clearance?

Affinity Fusion™ Oxygenator System received FDA 510(k) clearance on 2023-04-06, under 510(k) number K230640.

Who is the listed applicant for Affinity Fusion™ Oxygenator System?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Affinity Fusion™ Oxygenator System?

The FDA product code for Affinity Fusion™ Oxygenator System is DTZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITING NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

Other records listing Medtronic, Inc. as applicant

PMA P960009Stimulator, electrical, implanted, for parkinsonian tremor PMA P860004Pump, infusion, implanted, programmable PMA P130021Aortic valve, prosthesis, percutaneously delivered PMA P240013Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P100047Ventricular (assist) bypass PMA P980035Pulse generator, permanent, implantable

View all 166 devices →

Related Devices (Code: DTZ)

K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.