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Found 22 results
510(k) Data Aggregation
K Number
K232945Device Name
Trio-CT® Triple Lumen Catheter w/ Curved Extensions
Manufacturer
Medical Components Inc. (Dba MedComp)
Date Cleared
2023-11-16
(57 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
• The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
Device Description
The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
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K Number
K210461Device Name
End Cap
Manufacturer
Medical Components Inc. (Medcomp)
Date Cleared
2021-09-14
(210 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Luer lock plug for capping male or female luer tapers for hemodialysis catheters.
Device Description
The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.
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K Number
K202176Device Name
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
Manufacturer
Medical Components Inc. (Dba Medcomp)
Date Cleared
2020-09-03
(30 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
Device Description
The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
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K Number
K192807Device Name
Duo-Flow Side x Side Double Lumen Catheter
Manufacturer
Medical Components Inc. (dba MedComp)
Date Cleared
2020-04-23
(205 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Device Description
The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).
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K Number
K183219Device Name
Trio-CT Triple Lumen Catheter
Manufacturer
Medical Components Inc. (dba MedComp)
Date Cleared
2019-06-14
(206 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
Device Description
The Trio-CT™ Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
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K Number
K181175Device Name
12F Tri-Flow Triple Lumen Catheter
Manufacturer
Medical Components Inc. (Dba Medcomp)
Date Cleared
2018-07-05
(64 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Medical Components Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
Device Description
The 12F Tri-Flow Triple Lumen Catheter is a short term dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.
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K Number
K141633Device Name
PRO-PICC WITH VALVE TECHNOLOGY
Manufacturer
MEDICAL COMPONENTS INC
Date Cleared
2014-09-29
(103 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPONENTS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Device Description
The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.
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K Number
K132880Device Name
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
Manufacturer
MEDICAL COMPONENTS INC
Date Cleared
2014-01-08
(117 days)
Product Code
FPA, PTI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPONENTS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medcomp® Power Injectable Huber Needle Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Huber Needle Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 19 gauge and 20 gauge non-coring Huber style needles and 2 ml/sec for 22 gauge noncoring Huber style needles.
Device Description
The Power Injectable Safety Huber Needle is composed of a sharpened anti-coring Huber style needle for port septum access having a safety feature which is manually operated and will prevent accidental needle sticks when advanced which is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.
The proximal end of the needle cannula is adhesively sealed to the molded housing which contains a glue well and fluid thru hole thru hole leads to the distal end of the extension line set that is also adhesively bonded in the molded housing. The distal end of the extension tubing contains a female luer connector with removable dust cap on the proximal end creating a fluid path from the needle tip thru the female luer. The infusion set is also offered in a configuration where the extension tubing contains a Y-Site connector with removable dust cap placed midway between the needle and the female luer connector. The extension tubing contains purple pigment to indicate its use for high pressure. The Y portion of the connector is a molded female luer that is sealed with a removable dust cap. A non-removable pinch clamp is located between the female luer and needle cannula. On line sets with a Y-Site connector, two pinch clamps are present located between the female luer and the Y-Site and the Y-Site and the needle cannula. The pinch clamps are designed that when engaged, fluid flow is restricted thru the extension tubing.
The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.
The molded wing housing is of plastic construction and contains rigid protruding wings.
The molded wing housing is snap fitted into the molded housing via a securement post. The wing housing is of plastic construction with a protruding wing designed flush with the under surface of the housing. The wing housing contains a thru hole that easily slides over the needle cannula. The wing housing contains a torsion spring that is positioned on a post and is orientated in a positioning channel. The torsion spring is in a compressed state until the molded housing is removed from the wing housing at which time the torsion spring is automatically activated. The wing housing consists of a base to which the securement bag is adhesively bonded.
The molded housing is connected to the wing housing via the securement bag. The securement bag (a polyester film lamination) is adhesively bonded to the molded housing and the wing housing. The securement bag is compressed (accordion style) between the molded housing and wing housing and is of length sufficient to activate the torsion spring and to prevent the needle tip from entering the securement bag area.
In normal operation, the molded housing is activated during removal of the needle from the patient. The wing housing is held firmly in place while the molded housing is disengaged. The molded housing is disengaged from the wing housing by grasping the elevated portion of the molded housing and sliding the molded housing in an upward direction. The molded housing will disengage from the wing housing and will advance until the torsion spring is past the needle tip at which time the torsion spring will snap over the needle access hole. Upon spring activation, there will be an audible click sound as the spring snaps against the wing housing. The securement bag prevents the molded housing from advancing off the needle cannula and the torsion spring prevents the needle from advancing out of the housing.
Prior to use, the exposed portion of the needle cannula, including the sharpened needle tip area, is coated with a silicone fluid to render the needle lubricious and to reduce the insertion (penetration) and drag force to industry acceptable values.
Each needle size has I.D. Rings located within the pinch clamp to identify the appropriate infusion rate for the noted needle gauge size. Components will be assembled by the manufacturer into standard configurations with or without the "Y-Site" and packaged.
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K Number
K131687Device Name
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
Manufacturer
MEDICAL COMPONENTS INC
Date Cleared
2013-08-16
(67 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPONENTS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.
Device Description
The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion.
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K Number
K130687Device Name
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
Manufacturer
MEDICAL COMPONENTS INC
Date Cleared
2013-08-15
(155 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPONENTS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children.
Device Description
The Medcomp 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique. The purpose of the device is to facilitate the insertion of a peripheral, mid-line, or central venous catheter. The introducer is inserted over a .010 inch diameter guidewire that has been placed into the target vessel using a needle or IV catheter. Upon placement of the introducer, the guidewire is removed. When the catheter is ready for insertion, the dilator of the introducer is withdrawn from the sheath and the catheter is threaded into the vein through the sheath. When the catheter has been placed, the sheath is simultaneously split and withdrawn leaving the catheter in place. The Vascu-Sheath Tearaway Introducer is packaged sterile in either a pouch or a variety of tray configurations with additional accessories to facilitate catheter insertion.
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