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510(k) Data Aggregation
K Number
K031361Device Name
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
Manufacturer
DELTEC, INC.
Date Cleared
2003-05-23
(23 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
Device Description
The CADD® High-Volume Administration Sets with FlowStop is a modification to the current CADD® High-Volume Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The FlowStop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the "CLIP" must be removed to activate the FlowStop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the FlowStop in the open position. The Add-on Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the FlowStop.
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K Number
K030983Device Name
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY
Manufacturer
DELTEC, INC.
Date Cleared
2003-04-25
(28 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters are indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis.
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
Device Description
The catheters are long-term 12.5 French dual lumen straight polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. The catheters include a preattached in-growth cuff. Catheters will be offered in multi-unit packaging and with accessory components.
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K Number
K022221Device Name
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
Manufacturer
DELTEC, INC.
Date Cleared
2003-01-30
(205 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute hemodialysis and apheresis.
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
TruFlow™ Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
Device Description
The catheters are long- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.
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K Number
K020655Device Name
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
Manufacturer
DELTEC, INC.
Date Cleared
2002-08-13
(165 days)
Product Code
LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.
The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump.
Device Description
The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.
The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.
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K Number
K021999Device Name
GRIPPER PLUS NEEDLE
Manufacturer
DELTEC, INC.
Date Cleared
2002-08-13
(55 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
Device Description
The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.
The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.
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K Number
K010426Device Name
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
Manufacturer
SIMS DELTEC, INC.
Date Cleared
2001-03-08
(23 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000842Device Name
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
Manufacturer
SIMS DELTEC, INC.
Date Cleared
2000-06-08
(85 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000942Device Name
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
Manufacturer
SIMS DELTEC, INC.
Date Cleared
2000-04-27
(35 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994216Device Name
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
Manufacturer
SIMS DELTEC, INC.
Date Cleared
2000-01-27
(43 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Device Description
Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.
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K Number
K992697Device Name
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
Manufacturer
SIMS DELTEC, INC.
Date Cleared
1999-11-18
(99 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.
Device Description
A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.
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