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510(k) Data Aggregation
K Number
K152082Device Name
Vesocclude Polymer Ligating Clip
Manufacturer
Date Cleared
2016-02-26
(214 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Vesocclude Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Device Description
The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
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K Number
K091060Device Name
VESOCCLUDE LIGATING CLIP
Manufacturer
Date Cleared
2009-09-23
(162 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
VESOCCLUDE MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.
Device Description
Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.
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