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510(k) Data Aggregation
K Number
K033473Device Name
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2003-11-18
(15 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Device Description
The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
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K Number
K032754Device Name
VORTEX MP
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2003-09-12
(7 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Device Description
The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.
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K Number
K032557Device Name
TRIUMPH VTX WITH LIFEVALVE CATHETER
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2003-09-09
(21 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.
Device Description
The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.
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K Number
K031718Device Name
LIFEVALVE CENTRAL VENOUS CATHTER
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2003-07-02
(29 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeValve Central Venous Catheter is indicated for patient therapy requiring acute or long-term (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples.
Device Description
The LifeValve Central Venous Catheter includes a catheter and introduction components. The catheter is a percutaneous central venous catheter that incorporates a bidirectional valve assembly at the distal tip. The catheter is comprised of radiopaque silicone tubing, a molded radiopaque silicone tip with radiopaque marker band and a polvester implant cuff. It utilizes a luer lock connector and catheter Snap-Lock™ for proximal fittings. The catheter is equipped with a stylet stiffener. Each product is packaged in a sterile tray with 8 French introducer components. The family of LifeValve products includes externally communicating central venous catheters in two overall lengths, 50 and 65 cm.
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K Number
K022905Device Name
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2002-12-13
(101 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation.
The lumens are connected to the extensions via a molded hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement.
The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.
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K Number
K013871Device Name
LIFEGUARD SAFETY INFUSION SET
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2002-03-29
(128 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeGuard™ Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion Set facilitates safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.
Device Description
The LifeGuard™ Infusion Set is a standard 90° non-coring needle intravascular administration set with a sharps injury protection. The LifeGuard™ Infusion Set is designed for use with vascular access devices. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. The components that comprise the LifeGuard™ Safety Infusion Set includes the following: a PVC tubing set; a white clamp to prevent fluid flow; a universal female luer lock connector to connect to infusion/aspiration devices; a white cap to close the female luer; a winged needle holder to secure the infusion set to the patient with a pre-attached 90° non-coring needle to access the implanted port and allow the user to pull the needle up into the safety position; a needle trap encapsulates the needle after de-accessing the needle from the implanted port; and a needle guard shrouds the needle before use. Some models include a Ysite as an alternate female luer injection site with an additional white cap and white clamp to prevent fluid flow. A thermoformed tray with a heat sealed tyvek lid provides a sterile barrier. The LifeGuard™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The LifeGuard™ Safety Infusion Sets are supplied as sterile, non-latex, nonpyrogenic, intended for single use only and are manufactured out of non-DEHP PVC. De-accessing the needle is done as with any standard non-coring needle, using a one-handed (dominant hand) technique to remove the needle while stabilizing the port with the nondominate hand. As the needle is removed, the passive sharps injury protection feature is actuated by sliding the needle holder upward, · which encapsulates the needle within the needle trap.
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K Number
K011916Device Name
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2001-10-31
(133 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Super C™ Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis. hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The Super C™ Hemodialysis/Apheresis Chronic Catheter is composed of a radiopague polyurethane catheter shaft with two lumens (arterial and venous) in a Crescent (Circle "C") configuration. The lumens are distinguishable by color-coded clamps on clear silicone extensions. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement. The Super C™ Hemodialysis/Apheresis Chronic Catheter offered in straight versions are available in 19 cm, 23 cm, and 28 cm cuff to tip insertion lengths. Additionally, the Super C™ Hemodialysis/Apheresis Chronic Catheter is available with a J-Cannula version in 19 cm and 23 cm cuff to tip insertion lengths.
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K Number
K010767Device Name
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2001-04-10
(27 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010189Device Name
VORTEX ACCESS SYSTEM
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2001-02-12
(21 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994196Device Name
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
Manufacturer
HORIZON MEDICAL PRODUCTS, INC.
Date Cleared
2000-02-10
(59 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroPort 2 System is indicated for peripheral placement in the midarm, above the anticubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Device Description
The Horizon Medical Products MicroPort 2 system consist of a low profile ellipsoidal port made of Titanium and an attachable Polyurethane catheter. The catheter is attached to the port body by placing the catheter and strain relief connector over the barbed stem (outlet tube) of the body. The port body is implanted in the mid-arm (above the elbow). Implantation in the mid-arm avoids the bend in the elbow, which could place the catheter under added stress. The catheter reaches the central venous circulation via either the basilic or axillary vein. The veins in the upper arm are larger and offer a less tortuous path to the central venous circulation, making insertion easier. Additionally, this catheter route lessens the danger of pneumothorax, hemopneumothorax, air embolism, as well as catheter shear (Note: Catheter does not pass between the clavicle and the first rib.).
The MicroPort 2 Peripheral Access System is packaged without and with kit introducer components. The kit contains basic components required for percutaneous. The system is sterilized by ethylene oxide gas and is labeled as a sterile as well as a single use only device.
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