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510(k) Data Aggregation
K Number
K192230Device Name
MF SAFECATH
Manufacturer
Date Cleared
2020-04-23
(251 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
MediFirst Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MF SAFECATH, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Device Description
This medical device is a disposable intravascular tube catheter composed of cap, cannula, catheter tube, catheter hub, gasket, g-holder, cannula hub, plug, filter. This device has a passive needlestick safety feature that prevents the cannula from escaping forward during the use. MF SAFECATH are available in 16G, 18G, 20G, 22G, and 24G and various lengths.
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