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510(k) Data Aggregation
K Number
K130725Device Name
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
Manufacturer
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
Date Cleared
2013-04-17
(30 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.
Device Description
The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.
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K Number
K112511Device Name
DOBBHOFF DUAL PORT FEEDING TUBE
Manufacturer
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
Date Cleared
2012-05-11
(255 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DOBBHOFF™ Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
Device Description
The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feeding tubes include an external proximal access port for connection to enteral feeding sets and to oral tip, enteral syringes. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube and, if a stylet was in place during tube insertion, to assist with removal of the stylet. The stylet is made of specially designed metal wire which may be optionally utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the amount of tube inserted into the alimentary tract.
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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?
Applicant Name (Manufacturer) :
KENDALL
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
K092205Device Name
PALINDROME P HEMODIALYSIS CATHETER
Manufacturer
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
Date Cleared
2009-10-30
(100 days)
Product Code
MSD, NFK
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palindrome P Hemodialysis Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.
The Palindrome P Catheter Repair Kit is indicated to repair the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s) of the Palindrome P Hemodialysis Catheter
The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.
The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm
Device Description
The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The Catheter will be supplied with a detached connector assembly allowing for the catheter tip to be positioned in the vein and tunneled retrograde to the exit site. The hub and back end of the catheter is then assembled with a snap lock connector with compression ring.
A Palindrome™ Reverse Tunneled catheter repair kit will be offered to replace damaged extensions and / or extension adaptors.
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K Number
K062671Device Name
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
Manufacturer
KENDALL
Date Cleared
2006-11-03
(56 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.
The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.
Device Description
The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
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K Number
K061936Device Name
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
Manufacturer
THE KENDALL COMPANY
Date Cleared
2006-08-09
(30 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.
The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.
Device Description
The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.
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K Number
K060972Device Name
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
Manufacturer
KENDALL
Date Cleared
2006-08-04
(119 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.
Device Description
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
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K Number
K060339Device Name
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
Manufacturer
TYCO HEALTHCARE/KENDALL
Date Cleared
2006-04-28
(77 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
TYCO HEALTHCARE/KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Device Description
The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.
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K Number
K053410Device Name
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
Manufacturer
KENDALL
Date Cleared
2006-01-06
(30 days)
Product Code
FEG
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.
Device Description
The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.
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K Number
K051805Device Name
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
Manufacturer
TYCO HEALTHCARE/KENDALL
Date Cleared
2005-10-13
(100 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TYCO HEALTHCARE/KENDALL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Device Description
Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.
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