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510(k) Data Aggregation
K Number
K013664Device Name
COALESCENT SURGICAL U-CLIP
Manufacturer
COALESCENT SURGICAL
Date Cleared
2002-01-24
(79 days)
Product Code
NCA
Regulation Number
878.4300Why did this record match?
Product Code :
NCA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.
Device Description
The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.
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K Number
K011589Device Name
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M
Manufacturer
BYPASS LTD.
Date Cleared
2001-12-26
(217 days)
Product Code
NCA, FZP
Regulation Number
878.4300Why did this record match?
Product Code :
NCA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.
Device Description
The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.
The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends.
The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.
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K Number
K003446Device Name
SYMMETRY AORTIC CLIP SYSTEM
Manufacturer
ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC.
Date Cleared
2001-05-21
(196 days)
Product Code
NCA, FZP
Regulation Number
878.4300Why did this record match?
Product Code :
NCA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.
Device Description
The Aortic Connector System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The Symmetry Aortic Connector System consists of a self expanding implantable connector and delivery system.
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