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510(k) Data Aggregation
K Number
K120349Device Name
SONIXGPS VASCULAR ACCESS NEEDLE KIT
Manufacturer
Date Cleared
2012-04-09
(63 days)
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
ULTRASONIX MEDICAL CORPATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.
Device Description
The SonixGPS™ Vascular Access Needle Kit includes: Vascular Access Needle: Disposable sterile vascular access needle Sensor Introducer: Disposable sterile sensor introducer into which the needle sensor (K111818) is inserted Cover: Disposable sterile cover provides a barrier to prevent transfer of microorganisms, body fluids and' particulate material to the reusable component.
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