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510(k) Data Aggregation
K Number
K063469Device Name
MEDICAN ALPHA
Manufacturer
Date Cleared
2006-12-01
(15 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
EASTERN MEDIKIT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intravascular catheter is a medical device intended to be used to introduce fluids or medicament through the peripheral veins and / or withdrawal of blood samples.
Intravascular catheter comprises of a short flexible plastic tube (the Catheter) which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded.
The intravascular catheter is used in aseptic environment.
Federal law (USA) restricts this device to sale by or on the order of a physician.
- Infusion of I.V. Solutions.
- Intermittent intravenous Drug administration.
Device Description
As per ISO 10555-1, the generic definition of an intravascular catheter is - Intravascular catheter is a tubular device, single or multi lumen, designed to be partially or totally inserted into the cardiovascular system for diagnostic and/or therapeutic purpose
The device under this submission is an over-needle-peripheral catheter.
Over - the - needle peripheral intravascular catheters are intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. These catheters are designed for the introduction or withdrawal of liquids into or from the peripheral vascular system.
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