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510(k) Data Aggregation
K Number
K152765Device Name
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
Manufacturer
B.BRAUN INTERVENTIONAL SYSTEMS INC.
Date Cleared
2016-02-26
(155 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
B.BRAUN INTERVENTIONAL SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VenaTech® Convertible™ Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
- · Pulmonary thromboembolism when anticoagulants are contraindicated;
- · Failure of anticoagulant therapy in thromboembolic diseases;
- · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced: and
- · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the 'Conversion Procedure' in the Instructions for Use.
Device Description
The VenaTech Convertible Vena Cava Filter is a flexible, symmetrical, cobalt-chromium metal alloy, self-expanding vena cava filter intended for permanent implantation into the infrarenal inferior vena cava to provide protection against pulmonary embolism. When clinically indicated, the clot-trapping features of the VenaTech Convertible filter can be deactivated by percutaneously converting the filter to an open configuration. The VenaTech Convertible filter is pre-loaded in a cartridge (syringe) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either using the femoral or jugular approach.
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