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510(k) Data Aggregation
K Number
K041338Device Name
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
2004-07-19
(60 days)
Product Code
MWS
Regulation Number
870.4500Why did this record match?
Product Code :
MWS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
Device Description
The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.
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K Number
K992476Device Name
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-09-13
(415 days)
Product Code
MWS, MMS
Regulation Number
870.4500Why did this record match?
Product Code :
MWS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
Device Description
Pilling Weck Surgical Stabilizer Removable Pads
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K Number
K992833Device Name
VACUUM ASSIST STABILIZER
Manufacturer
CARDIO THORACIC SYSTEMS
Date Cleared
1999-11-10
(79 days)
Product Code
MWS
Regulation Number
870.4500Why did this record match?
Product Code :
MWS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
Device Description
The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
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K Number
K982419Device Name
HEART-LIFT BALLOON POSITIONER
Manufacturer
CARDIOTHORACIC SYSTEMS, INC.
Date Cleared
1999-01-13
(184 days)
Product Code
MWS
Regulation Number
870.4500Why did this record match?
Product Code :
MWS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
Device Description
The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
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