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510(k) Data Aggregation
K Number
K990503Device Name
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
Manufacturer
SULZERMEDICA
Date Cleared
1999-12-09
(295 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
SULZERMEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.
Device Description
The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft with a base graft porosity of 2118 ml/cm³/min. The knitted polyester material has been impregnated with an absorbable mammalian gelatin that seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.
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