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510(k) Data Aggregation
K Number
K031783Device Name
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
Manufacturer
INTRAVASCULAR INCORPORATED
Date Cleared
2003-07-01
(21 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
INTRAVASCULAR INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
Device Description
The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.
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K Number
K023585Device Name
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
Manufacturer
INTRAVASCULAR INCORPORATED
Date Cleared
2002-11-21
(27 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
INTRAVASCULAR INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.
Device Description
The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.
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