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510(k) Data Aggregation
K Number
K221473Device Name
Flowart
Manufacturer
Date Cleared
2022-09-26
(129 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Asset Medikal Tasarim AS.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.
Needleless valve allows the user to add medication into the without the use of a needle.
Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
Device Description
Not Found
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K Number
K221481Device Name
NeutrArt
Manufacturer
Date Cleared
2022-09-23
(123 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Asset Medikal Tasarim AS.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.
Needleless valve allows the user to add medication into the without the use of a needle.
Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
Device Description
Not Found
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K Number
K201872Device Name
NeutrArt
Manufacturer
Date Cleared
2021-01-05
(182 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Asset Medikal Tasarim AS.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.
Stopcocks are intended for use to change the direction of fluids through a tubing set.
Needleless valve allows the user to add medication into the without the use of a needle.
Device Description
Not Found
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