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510(k) Data Aggregation
K Number
K122735Device Name
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
Manufacturer
Date Cleared
2013-05-21
(257 days)
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
SORIN GROUP USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
Device Description
The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be cut. The cannula allows the ligation loops to be placed and tightened from a single central incision. The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula. This assembly is packaged in a paper envelope and sealed in a Tyvek - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.
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