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Found 11 results
510(k) Data Aggregation
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
K024010Device Name
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
Manufacturer
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
Date Cleared
2003-06-11
(189 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY DIV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Device Description
The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
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K Number
K030209Device Name
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
Manufacturer
THE KENDALL COMPANY
Date Cleared
2003-05-13
(112 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAHURKAR® QPLUS® Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Device Description
The MAHURKAR® QPLUS® Catheter has a 13.5Fr radiopaque polyurethane catheter shaft with two large lumens (arterial and venous) running longitudinally along the length of the catheter shaft. The catheter version with a straight shaft either has curved extensions or straight extensions. The catheter version with a pre-curved shaft has straight extensions.
MAHURKAR® QPLUS® Catheter is available in kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.
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K Number
K020089Device Name
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
Manufacturer
THE KENDALL COMPANY
Date Cleared
2002-04-10
(90 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAHURKAR® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Device Description
The MAHURKAR® Triple Lumen Catheter features three lumens. The catheter has a 12 Fr radiopaque polyurethane catheter shaft with two large lumens and one smaller medial lumen running longitudinally along the length of the catheter shaft. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions. The two large lumens have curved extensions, and the smaller medial lumen has straight extension tubing. The catheter is available in various implantable lengths.
MAHURKAR® Triple Lumen Catheter is available in singles, kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.
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K Number
K011283Device Name
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-10-15
(171 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011941Device Name
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-08-22
(62 days)
Product Code
FRO, EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.
Device Description
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.
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K Number
K002902Device Name
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-04-09
(203 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002901Device Name
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-03-28
(191 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003313Device Name
FILAC FAS TEMP ELECTRONIC THERMOMETER
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-01-11
(80 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990530Device Name
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
Manufacturer
THE KENDALL COMPANY, L.P.
Date Cleared
2000-01-31
(346 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY, L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
Device Description
The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.
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