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510(k) Data Aggregation
K Number
K190816Device Name
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
Manufacturer
Date Cleared
2019-11-19
(235 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Avenir Performance Europeenne Medical (APEM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vials Adapters Ø20 mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials.
Device Description
The vial Adapters (VA) Ø20mm and Ø13mm are sterile polycarbonated devices which allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of a vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in two Ø20 mm and Ø13mm diameter to accommodate respective size of drug vials and is available in 3 configurations, no filter, in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
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K Number
K190149Device Name
Vial Adapter Ø20 mm
Manufacturer
Date Cleared
2019-10-15
(259 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Avenir Performance Europeenne Medical (APEM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.
Device Description
The vial adapter (VA) are sterile polycarbonate molded devices that allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of the vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in Ø20mm to accommodate Ø20 drug vials and is available in 3 configurations, no filter, inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
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