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Found 8 results
510(k) Data Aggregation
K Number
K131517Device Name
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
Manufacturer
MEDRAD, INC. / BAYER MEDICAL CARE, INC.
Date Cleared
2013-08-02
(66 days)
Product Code
FPK, CLA
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.
Device Description
The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.
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K Number
K063114Device Name
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
Manufacturer
COEUR, INC.
Date Cleared
2007-02-09
(121 days)
Product Code
FPK, FPA
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe
Device Description
The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.
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K Number
K063239Device Name
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
Manufacturer
HOSPIRA, INC.
Date Cleared
2006-12-11
(46 days)
Product Code
FPK, FPA
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
Device Description
The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.
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K Number
K052431Device Name
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
Manufacturer
MEDTRONIC MINIMED
Date Cleared
2005-11-29
(84 days)
Product Code
FPK
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic MiniMed Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
Device Description
The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.
The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion.
The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.
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K Number
K041178Device Name
EMPOWER TRANSFER SET, (CAT. NO. 7725)
Manufacturer
E-Z-EM, INC.
Date Cleared
2004-07-16
(72 days)
Product Code
FPK
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.
Device Description
The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.
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K Number
K031808Device Name
MEDRAD SWABBABLE VALVE TRANSFER SET
Manufacturer
MEDRAD, INC.
Date Cleared
2003-07-11
(29 days)
Product Code
FPK, FPA
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Device Description
The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.
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K Number
K022431Device Name
MEDRAD TRANSFER SET
Manufacturer
MEDRAD, INC.
Date Cleared
2002-09-05
(42 days)
Product Code
FPK, LHI
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
Device Description
The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.
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K Number
K965208Device Name
POLYFIN EXTENSION SET, MODELS 126 AND 128
Manufacturer
MEDTRONIC MINIMED
Date Cleared
1997-02-26
(61 days)
Product Code
FPK
Regulation Number
880.5440Why did this record match?
Product Code :
FPK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.
Device Description
The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device at the proximal end to a medication reservoir, such as the MiniMed reservoir, model 103, and at the distal end to an infusion set such as the Polyfin infusion set, model 106. The Polyfin extension set may also be used to administer drugs labeled for intravenous administration from an external pump by attaching the distal end to a "Y-site" or "Heparin lock."
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