Search Results
Found 2 results
510(k) Data Aggregation
K Number
K060741Device Name
SWIRLGRAFT VASCULAR ACCESS GRAFT
Manufacturer
Date Cleared
2006-04-05
(16 days)
Product Code
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
VERYAN MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K051312Device Name
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
Manufacturer
Date Cleared
2005-11-04
(169 days)
Product Code
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
VERYAN MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.
The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access.
Device Description
The SwirlGraft™ Bypass and Vascular Access Grafts are 6 mm diameter expanded polytetraflouro-ethylene (ePTFE) vascular grafts that are manufactured with a small amplitude helical geometry along their length. The SwirlGraft™ Bypass Graft has a thin wall ePTFE construction and a full ePTFE external support. The SwirlGraft™ Vascular Access Graft is a standard wall ePTFE construction with no external support.
Ask a Question
Ask a specific question about this device
Page 1 of 1