Search Results
Found 1 results
510(k) Data Aggregation
K Number
K021547Device Name
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
Manufacturer
Date Cleared
2003-01-24
(259 days)
Product Code
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
JOTEC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral.
Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
Device Description
The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.
The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.
Ask a Question
Ask a specific question about this device
Page 1 of 1