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Found 6 results
510(k) Data Aggregation
K Number
K971339Device Name
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1997-12-24
(258 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
Device Description
The subject catheter is a short term, single use, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.
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K Number
K970259Device Name
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1997-04-08
(75 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.
Device Description
The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set.
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K Number
K964048Device Name
FIRST MIDCATH CATHETER KIT
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1997-01-06
(89 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above.
Device Description
The subject kit contains a long term, single use, single or dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site.
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K Number
K964049Device Name
FIRST MIDCATH CATHETER WITH DUAL LUMENS
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1997-01-06
(89 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.
Device Description
The subject catheter is a long term, single use, dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
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K Number
K964050Device Name
FIRST MIDCATH CATHETER
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1997-01-06
(89 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.
Device Description
The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
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K Number
K954906Device Name
FIRST PICC INTRODUCER CATHETER
Manufacturer
BECTON DICKINSON VASCULAR ACCESS, INC.
Date Cleared
1996-04-08
(166 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON VASCULAR ACCESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.
Device Description
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.
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