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510(k) Data Aggregation
K Number
K221411Device Name
Surflo Winged Infusion Set
Manufacturer
Terumo Medical Products (Hangzhou) Co., Ltd.
Date Cleared
2023-06-23
(403 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Terumo Medical Products (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.
Device Description
The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.
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K Number
K220934Device Name
RADIFOCUS Torque Device
Manufacturer
Terumo Medical Products (Hangzhou) Co., Ltd.
Date Cleared
2022-06-29
(90 days)
Product Code
MOF, PTL
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Terumo Medical Products (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
Device Description
RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures. This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.
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