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Found 13 results
510(k) Data Aggregation
K Number
K250105Device Name
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
Manufacturer
Aveera Medical, Inc.
Date Cleared
2025-07-03
(169 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K221902Device Name
LimFlow Vector
Manufacturer
LimFlow, Inc.
Date Cleared
2022-12-21
(174 days)
Product Code
MGZ, LIM
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
Device Description
The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.
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K Number
K190267Device Name
EZE SIT Valvulotome
Manufacturer
LeMaitre Vascular
Date Cleared
2019-10-30
(264 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
Device Description
The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.
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K Number
K142660Device Name
Antegrade LeMills Valvulotome
Manufacturer
LeMaitre Vascular, Inc.
Date Cleared
2014-10-17
(29 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LeMills Valvulotomes are intended to cut venous valves.
Device Description
The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
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K Number
K140042Device Name
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2014-04-10
(92 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.
Device Description
The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.
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K Number
K132047Device Name
LEMILLS VALVULOTOME
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2013-11-05
(126 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LeMills Valvulotome is intended to cut venous valves.
Device Description
The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
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K Number
K132190Device Name
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2013-08-05
(21 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
Device Description
The ELV and OTW-LV are self-centering and self-sizing valvulotome used for blind lysis of vein valves. Once the valves have been rendered ineffectual, it can then be utilized as an arterial conduit. Centering hoops keep the devices centered in the vein and prevent the valve-cutting blades from damaging the vein wall. The size of hoops and blades adjusts to the internal diameter of the vein as the valvulotome is being drawn through the vessel. The OTW-LV facilitates navigation of the vein with the assistance of a guidewire.
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K Number
K111884Device Name
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2011-07-29
(28 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.
Device Description
The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.
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K Number
K080178Device Name
VALVULOTOME BY KOVEN
Manufacturer
KOVEN TECHNOLOGY, INC.
Date Cleared
2008-07-28
(186 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
Device Description
The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.
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K Number
K022823Device Name
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
2004-07-01
(675 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Product Code :
MGZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.
Device Description
Not Found
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