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Found 16 results
510(k) Data Aggregation
K Number
K131659Device Name
MOERAE VEIN PREPARATION KIT
Manufacturer
MOERAE MATRIX, INC.
Date Cleared
2014-03-03
(270 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
Device Description
The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.
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K Number
K082725Device Name
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
Manufacturer
MAQUET CARDIOVASCULAR, LLC
Date Cleared
2008-12-17
(91 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
Device Description
The VASOSHIELD Pressure Controlling Syringe is identical to the InPress Syringe in design, materials, principles of operation, and manufacturing process. The syringe is comprised of 10 biocompatible components including a syringe, a syringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, black acetal pusher, a white acetal knob and body. The syringe has three predetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg. The syringe is a single use device, supplied sterile.
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K Number
K052286Device Name
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
Manufacturer
THE CATHETER EXCHANGE, INC.
Date Cleared
2005-10-21
(60 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.
The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.
Device Description
The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar.
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K Number
K043515Device Name
GRAFTSAVER
Manufacturer
VESCARE, INC.
Date Cleared
2005-03-31
(101 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use in the distention and irrigation of venous vessels prior to use as a bypass graft.
Device Description
The device is comprised of 10 biocompatible components including a syringe stopper, a oring and rod, a green acetal ring, a black acetal pusher, a white acetal knob and body. The device is packaged in a Tyvek blister peel pouch. The device is used for the preparation and irrigation of venous vessels prior to use as a bypass graft. The device has three settings which allow the user to limit the nominal pressure up to 150 mmHg, 250 mmHg or 350 mmHg.
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K Number
K013417Device Name
MISONIX IRRIGATION SYSTEM MOEDL BC20P
Manufacturer
MISONIX, INC.
Date Cleared
2002-01-10
(87 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties: General Surgical Procedures. The Misonix Irrigation System (BC20P) is not intended for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.
Device Description
The Misonix Irrigation System (BC20P) is a liquid transfer system. It is designed to utilize standard or custom tubing sets, which mate to IV bottles or bags, open reservoirs or other liquid canisters. The liquid is drawn through the pump head and then pressurized, allowing the liquid to be transferred from the source. The outlet of the tube set may be connected to a cannula or other orifice to allow flushing and cleaning of the site. It can be used to refill small containers from a larger reservoir. It is not intended for drug delivery or the administration of parenteral fluids.
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K Number
K000704Device Name
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
Manufacturer
DMC MEDICAL LTD.
Date Cleared
2000-05-19
(78 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974233Device Name
LYSONIX IRRIGATION SYSTEM
Manufacturer
LYSONIX, INC.
Date Cleared
1998-02-03
(83 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.
Device Description
The LySonix Irrigation System is a stand-alone version of the irrigation component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
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K Number
K973703Device Name
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
1997-12-04
(69 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
Device Description
The Jackson-Pratt® Hemaduct and the Jackson-Pratt Gold™ Hemaduct™ Wound Drains are made of silicone in a variety of sizes and are offered sterile in both flat and round configurations.
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K Number
K972635Device Name
ULTRACELL SUCTION SPONGE
Manufacturer
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-10-01
(79 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sponge drains are used during surgery to protect delicate tissue from trauma, absorb fluids and to act as a filter to aspirate
Device Description
Not Found
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K Number
K965146Device Name
FLAT CLOSED WOUND DRAIN WITH TROCAR
Manufacturer
AXIOM MEDICAL, INC.
Date Cleared
1997-03-10
(77 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Product Code :
GBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To drainage excessive body fluid away from the wound site in the Surgery or after Surgery
Device Description
This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following: Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered. Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered. Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.
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