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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?
Product Code :
NIE
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
K222170Device Name
Power Acute Triple Lumen Hemodialysis Catheter
Manufacturer
Health Line International Corporation
Date Cleared
2023-01-13
(176 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Device Description
The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.
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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?
Product Code :
NIE
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?
Product Code :
NIE
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
K143102Device Name
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex Inc.)
Date Cleared
2015-07-24
(268 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.
Device Description
The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec.
The catheters are packaged sterile with various components to facilitate insertion.
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K Number
K141531Device Name
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
2015-06-01
(357 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Device Description
Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.
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K Number
K133456Device Name
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
2014-09-24
(316 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Device Description
Power-Trialysis™ Short-Term Dialysis catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.
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K Number
K123292Device Name
T3
Manufacturer
MEDCOMP
Date Cleared
2013-06-11
(232 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, 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 T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.
The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.
The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.
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K Number
K102605Device Name
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
Manufacturer
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
Date Cleared
2010-12-22
(103 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Device Description
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
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K Number
K083675Device Name
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
2009-03-19
(98 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Product Code :
NIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.
Device Description
Not Found
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