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510(k) Data Aggregation
K Number
K070380Device Name
PORTACLAMP FLEX
Manufacturer
Date Cleared
2007-06-08
(120 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
CARDIO LIFE RESEARCH, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
Device Description
The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
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K Number
K033085Device Name
PORTACLAMP
Manufacturer
Date Cleared
2004-04-27
(211 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
CARDIO LIFE RESEARCH, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
Device Description
The Portaclamp™ is a disposable aortic clamping device that is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp™ consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta. and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
Ask a Question
Ask a specific question about this device
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