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510(k) Data Aggregation
K Number
K070034Device Name
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
Manufacturer
Date Cleared
2007-08-17
(226 days)
Product Code
Regulation Number
870.4500Why did this record match?
Product Code :
NQG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Device Description
Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.
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K Number
K070036Device Name
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
Manufacturer
Date Cleared
2007-08-17
(226 days)
Product Code
Regulation Number
870.4500Why did this record match?
Product Code :
NQG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Device Description
Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.
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K Number
K063844Device Name
REPROCESSED HEART STABILIZERS AND POSITIONERS
Manufacturer
Date Cleared
2007-03-15
(79 days)
Regulation Number
870.4500Why did this record match?
Product Code :
NQG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.
Device Description
Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction.
Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.
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