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Found 9 results
510(k) Data Aggregation
K Number
K201697Device Name
Umbilical Vessels Catheter
Manufacturer
Haolang Medical USA Corporation
Date Cleared
2021-05-06
(318 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
--- sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
Device Description
The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.
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 40 cm from the tip. Catheter placement must be confirmed by x-ray.
The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
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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?
Product Code :
FOS
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
K120304Device Name
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
Manufacturer
FOOTPRINT MEDICAL INC.
Date Cleared
2012-03-01
(29 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.
Device Description
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
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K Number
K091213Device Name
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
Manufacturer
FOOTPRINT MEDICAL
Date Cleared
2009-09-25
(151 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.
Device Description
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.
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K Number
K091214Device Name
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
Manufacturer
FOOTPRINT MEDICAL
Date Cleared
2009-09-25
(151 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.
Device Description
Not Found
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K Number
K081515Device Name
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
Manufacturer
NEOMED, INC.
Date Cleared
2008-07-21
(52 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.
Device Description
The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.
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K Number
K073596Device Name
NEOMED SINGLE LUMEN UMBILICAL CATHETER
Manufacturer
NEOMED, INC.
Date Cleared
2008-02-22
(63 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neo Med Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood , monitor blood parties of administer Fluids intravenously
Device Description
The NeoMed Single Lumen Umbilical Catheter is a silicone single lumen catheter with natural white barium sulfate included for radiopacity.
The device consists of the following main components: a single lumen umbilical catheter, a hub, and a luer lock connector, and 3 way stopcock with 2 female type connectors.
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K Number
K981630Device Name
VYGON DOUBLE LUMEN UMBILICAL CATHETER
Manufacturer
SCHIFF & CO.
Date Cleared
1998-10-01
(147 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
Device Description
Double Lumen Umbilical Catheter
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K Number
K963972Device Name
NEO-CARE DUAL LUMEN UMBILICAL CATHETER
Manufacturer
KLEIN-BAKER MEDICAL, INC.
Date Cleared
1996-12-24
(82 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Product Code :
FOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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