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Found 3 results
510(k) Data Aggregation
K Number
K992290Device Name
EXEL INJECTION PLUG WITH CAP
Manufacturer
Date Cleared
2000-02-23
(231 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
EXEL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".
Device Description
Not Found
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K Number
K963658Device Name
EXEL AVF SINGLE NEEDLE
Manufacturer
Date Cleared
1998-05-05
(609 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
EXEL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.
Device Description
EXEL SINGLE NEEDLE AVF
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K Number
K963659Device Name
EXEL I.V. ADMINISTRATION SET
Manufacturer
Date Cleared
1997-12-16
(469 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
EXEL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.
Device Description
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