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510(k) Data Aggregation
K Number
K182457Device Name
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
Manufacturer
Brivant Limited (Lake Region Medical)
Date Cleared
2019-04-18
(223 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Brivant Limited (Lake Region Medical)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Device Description
The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).
The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.
Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.
When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).
Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.
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K Number
K141831Device Name
HYDRAVIEW GUIDEWIRE
Manufacturer
BRIVANT LIMITED
Date Cleared
2014-09-04
(59 days)
Product Code
DQX, DOX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
BRIVANT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.
Device Description
The HydraView Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 30cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support; ES, DS and EDS.
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K Number
K060551Device Name
BRIVANT GUIDEWIRE
Manufacturer
BRIVANT LIMITED
Date Cleared
2006-06-07
(97 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
BRIVANT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Brivant guidewires are intended for use in the coronary and peripheral vasculature.
Device Description
The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.
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