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510(k) Data Aggregation
K Number
K010538Device Name
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
Manufacturer
Date Cleared
2001-03-30
(35 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RD MEDICAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001102Device Name
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
Manufacturer
Date Cleared
2000-04-20
(15 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RD MEDICAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000017Device Name
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
Manufacturer
Date Cleared
2000-02-10
(38 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RD MEDICAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K992104Device Name
PARSET, MODEL A10001E
Manufacturer
Date Cleared
1999-08-23
(62 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RD MEDICAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the proposed device is for the intravascular administration of fluids and medication by trained health care personnel. The administration of fluids is achieved through gravity from collapsible or non-collapsible fluid containers through a venipuncture device (not included in the proposed device).
The device is used to supply medication and fluids intravascularly to patients through a needle or catheter inserted into the vein.
Device Description
The proposed administration set will be used for intravascular administration of fluids and medication. The proposed device contains a vent with filter such that it can be used with non-collapsible fluid containers. The vent also has a cap to close the vent when using a collapsible fluid container (e.g., IV bag) which does not require a vent. The proposed device also contains an injection site 8 in. from the distal luer slip connector.
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