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Found 11 results
510(k) Data Aggregation
K Number
K101261Device 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
876.5540Why 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
K092797Device Name
ACUTE AND CHRONIC CATHETER REPAIR KIT
Manufacturer
KENDALL
Date Cleared
2009-11-19
(69 days)
Product Code
NFK
Regulation Number
876.5540Why 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
K063446Device 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
876.5540Why 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
K062435Device 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
876.5540Why 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
K030442Device 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
876.5540Why 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
K022644Device Name
RETRO REPAIR KIT, MODEL PRRK5
Manufacturer
SPIRE BIOMEDICAL, INC.
Date Cleared
2002-11-06
(90 days)
Product Code
NFK
Regulation Number
876.5540Why 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
K022570Device Name
MEDCOMP REPAIR KIT, MODEL ASPCRPK
Manufacturer
MEDCOMP
Date Cleared
2002-10-31
(90 days)
Product Code
NFK
Regulation Number
876.5540Why 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
K022561Device 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
876.5540Why 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
K020430Device Name
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
Manufacturer
DIATEK, INC.
Date Cleared
2002-05-09
(90 days)
Product Code
NFK
Regulation Number
876.5540Why 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
K011015Device 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
876.5540Why did this record match?
Product Code :
NFK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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