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510(k) Data Aggregation
K Number
K133445Device Name
ANGIOVAC CANNULA
Manufacturer
VORTEX MEDICAL INC
Date Cleared
2014-03-05
(113 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
VORTEX MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioVac Cannula is indicated for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Device Description
The AngioVac device is a 22 Fr cannula with a balloon-actuated, expandable, funnel shaped distal tip that can be advanced through a 26 Fr sheath over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit and a commercially available pump head and bubble trap. A commercially available reinfusion camula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. When the bypass pump is started, suction is created, removing blood and debris from around the tip of the Angio Vac cannula, circulating the blood through the filter, and returns the blood to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of clot material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. The device may be used in target vessels for thrombus/embolus extraction include, but are not limited to, the illiofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA).
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K Number
K092486Device Name
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
Manufacturer
VORTEX MEDICAL INC
Date Cleared
2009-08-28
(15 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Applicant Name (Manufacturer) :
VORTEX MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
Device Description
The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").
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K Number
K091304Device Name
VORTEX CANNULA
Manufacturer
VORTEX MEDICAL INC
Date Cleared
2009-07-02
(59 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
VORTEX MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.
Device Description
The Vortex Cannula is a wire reinforced, ranging from 22 to 26 French, device that is of appropriate stiffness and flexibility so that it can be manipulated throughout the vascular svstem. The cannula is rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula. The cannula has a proprietary distal end with a balloon activated, expandable, funnel-shaped tip that willenhance flow when the balloon is activated and will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices and facilitate en-bloc removal of such material from the vascular system. The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit. The cannula will be shipped to the user in a sterile package and ready for use.
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