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510(k) Data Aggregation
K Number
K150882Device Name
Edwards Suture Fastening System
Manufacturer
EDWARDS LIFESCIENCES, LLC.
Date Cleared
2015-06-16
(75 days)
Product Code
HCF
Regulation Number
878.4800Why did this record match?
Product Code :
HCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
Device Description
The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.
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