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510(k) Data Aggregation
K Number
K111064Device Name
TIGERPAW SYSTEM II
Manufacturer
LAAX, INC.
Date Cleared
2011-05-18
(30 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
LAAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Device Description
The TigerPaw® System II consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and exclude the LAA. The TigerPaw System II also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with two triggers that when separately actuated, close opposing jaws thus mating the two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.
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K Number
K101961Device Name
TIGERPAW SYSTEM
Manufacturer
LAAX, INC.
Date Cleared
2010-10-29
(109 days)
Product Code
GDW, GOW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
LAAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TigerPaw® System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Device Description
The TigerPaw System consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and completely exclude the LAA. The TigerPaw® System also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with triggers that when actuated close jaws that in turn mate the two sides of the permanently implanted Fastener together.
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