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510(k) Data Aggregation
K Number
K123571Device Name
CARDIO VISION MICS AORTIC CLAMPS
Manufacturer
CARDIOMEDICAL GMBH
Date Cleared
2013-08-01
(254 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Device Description
Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular clamps provided with DeBakey tooth design. The closure mechanisms permit the surgeon to adjust the amount of tension applied to the vessel. The length and design of the clamps can be important to keep the devices out of the field of vision of the operative site. Three basic models are available to accommodate the individual needs of the surgeon and the procedure based on the anatomy of the site. Standard Clamp - Ring-handled clamp with ratchet closure o 2nd Generation Clamp -- Handleless clamp with manual screw 0 mechanism closure Clamp by Glauber - Handleless clamp with screw mechanism closure. o The clamp is positioned and removed by means of an applicator and remains wholly within the thorax throughout the duration of the procedure. The device is provided non-sterile for steam sterilization by the user.
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