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510(k) Data Aggregation

    K Number
    K101261
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2010-07-29

    (85 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.
    Device Description
    The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing exists. The repair kit components are made from Delrin.
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    K Number
    K092797
    Device Name
    ACUTE AND CHRONIC CATHETER REPAIR KIT
    Manufacturer
    KENDALL
    Date Cleared
    2009-11-19

    (69 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: Palindrome ™ Chronic Care Catheters, Palindrome TM Emerald™ Chronic Care Catheters, Palindrome ™ Ruby™ Chronic Care Catheters, Palindrome™ Sapphire™ Chronic Care Catheters, MAHURKAR™* Maxid™ Chronic Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 11.5 Fr. (3.83mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters, MAHURKAR™* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)
    Device Description
    The Covidien™ Acute and Chronic Catheter Repair Kit is intended to be used for the repair of a broken luer adapter, clamp, or extension tubing (only the most proximal 0.5-cm of tubing) of an existing catheter. When one of these components is damaged the implanted catheter will be clamped off using the existing clamp and a slide clamp that will be provided as apart of the catheter repair kit. Then the damaged extension tube will be cut off and the existing clamp will be removed while the slide clamp will provide the stasis of the catheter. After removing the existing clamp a threaded repair collar will be placed over the remaining extension tube. The barbed connector will then be inserted barb end first into the extension tube. Once in place the repair collar will be threaded onto the new repaired back end to secure the placement
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    K Number
    K063446
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2006-12-15

    (30 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Term Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* II Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.
    Device Description
    The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
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    K Number
    K062435
    Device Name
    REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Date Cleared
    2006-12-05

    (106 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.
    Device Description
    The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.
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    K Number
    K030442
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2003-07-21

    (160 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term Hemodialysis Catheter.
    Device Description
    The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
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    K Number
    K022644
    Device Name
    RETRO REPAIR KIT, MODEL PRRK5
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Date Cleared
    2002-11-06

    (90 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO catheters.
    Device Description
    Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO Twin Lumen Silicone Hemodialysis Catheters with Separated Tips.
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    K Number
    K022570
    Device Name
    MEDCOMP REPAIR KIT, MODEL ASPCRPK
    Manufacturer
    MEDCOMP
    Date Cleared
    2002-10-31

    (90 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE MEDCOMP REPAIR KIT IS INDICATED FOR USE IN REPLACING DAMAGED FEMALE LUER CONNECTORS, CLAMPS, OR REPAIRING EXTENSIONS WHERE THERE IS A MINIMUM OF 4.5cm VIABLE EXTENSION TUBING. REPAIRS MEDCOMP CATHETERS: 10F Ash Split Cath® XL, 10F Ash Split Cath® II, 14F Ash Split Cath®, 14F Ash Split Cath® XL, 14F Ash Split Cath® II, 16F Ash Split Cath® II
    Device Description
    The Medcomp Repair Kit is two-piece replacement luer adaptor and cap used to repair damaged female luer connectors on Medcomp Hemodialysis Catheters. The Medcomp Repair Kit also consists of replacement arterial and venous clamps.
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    K Number
    K022561
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2002-08-23

    (21 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.
    Device Description
    The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
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    K Number
    K020430
    Device Name
    DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
    Manufacturer
    DIATEK, INC.
    Date Cleared
    2002-05-09

    (90 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement. The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath implanted.
    Device Description
    The Diatek Connector Assembly Replacement Kit consists of a Cannon-Cath connector assembly and components needed to remove the previously implanted connector assembly and attach the new connector assembly to the previously implanted dialysis catheter.
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    K Number
    K011015
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2001-06-22

    (79 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    NFK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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