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510(k) Data Aggregation
K Number
K955121Device Name
HEARTPORT ENDOARTERIAL RETURN CANNUALManufacturer
Date Cleared
1996-05-10
(183 days)
Product Code
Regulation Number
870.4210Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter into the femoral artery.
Device Description
This post-enactment device is an extracorporeal cannula used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment.
AI/ML Overview
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