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510(k) Data Aggregation
K Number
K032436Device Name
DURAMAX .018 BILIARY STENT SYSTEM
Manufacturer
AVANTEC VASCULAR CORP.
Date Cleared
2004-02-04
(181 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
AVANTEC VASCULAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuraMax™.018 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree
Device Description
The DuraMax™.018 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤0.018" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 5, 6 & 7 mm in lengths of 13, and 18 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.
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K Number
K030638Device Name
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
Manufacturer
AVANTEC VASCULAR CORP.
Date Cleared
2003-07-09
(131 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
AVANTEC VASCULAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Device Description
The DuraMax™ .035 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤ 0.035" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 7, 8, 9 & 10 mm in lengths of 18, 28 and 28 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.
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K Number
K030062Device Name
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
Manufacturer
AVANTEC VASCULAR CORP.
Date Cleared
2003-04-03
(86 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
AVANTEC VASCULAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.
Device Description
The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial, dual lumen design with a inflatable balloon on the distal end and compatible with 0.035" guidewires. Two radiopaque markers indicate the dilating portion of the balloon and aid in balloon placement. The device is available with balloon diameters of 7.0 - 10.0 mm, balloon lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.
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