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510(k) Data Aggregation
K Number
K251358Device Name
Bridge Plus Occlusion Balloon (590-002)
Manufacturer
Philips Image Guided Therapy Devices
Date Cleared
2025-06-24
(55 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Philips Image Guided Therapy Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.
Device Description
The Bridge Plus Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) or the inferior vena cava (IVC) for the purpose of providing occlusion, emergency control of hemorrhage and perioperative occlusion in the event of an SVC or IVC tear or perforation during a vascular procedure.
The Bridge Plus Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a 12Fr dual lumen nylon shaft. This guidewire lumen is used to pass the catheter over a guidewire. The balloon has a length of 80mm and inflation diameter ranging from 20-29mm. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC or IVC prior to inflation.
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