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510(k) Data Aggregation
K Number
K243061Device Name
SonoStik Guide Wire Introducer
Manufacturer
Date Cleared
2024-11-04
(38 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
SonoStik, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
Device Description
The SonoStik Guide Wire Introducer is intended to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, Advancing Wheels, and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of a compatible needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as they engage the introducer wheel.
The SonoStik Guide Wire Introducer is compatible with and intended to be used with the MedSource Labs VeroTrue Conventional IV Catheter (K193278 catheter and needle set in 18-, 20-, and 22-gauge sizes.
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K Number
K152177Device Name
SonoStik IV Guide Wire Introducer
Manufacturer
Date Cleared
2015-10-01
(58 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
SONOSTIK, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
Device Description
The SonoStik Guide Wire Introducer is intended to facilitate placing a catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, an Advancing Wheel and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of the needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as he/she engages the introducer wheel.
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