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510(k) Data Aggregation
K Number
K011464Device Name
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN
Manufacturer
Date Cleared
2001-06-13
(30 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR INTERVENTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K971588Device Name
EVI SUTURED-CLIP APPLIER
Manufacturer
Date Cleared
1997-10-24
(176 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
ELECTIVE VASCULAR INTERVENTION INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.
Device Description
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
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