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510(k) Data Aggregation
K Number
K092097Device Name
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
Manufacturer
Date Cleared
2010-05-06
(296 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
A.B. KORKOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AngioXpand Introducer Catheter is intended to facilitate placement of other devices such as guidewires or catheters through the skin into the vascular system.
Device Description
The AngioXpand Introducer Catheter is a medical device composed of a disposable needle and catheter. The device is equivalent in intended use to current legally marketed introducer catheter devices, and utilizes the same catheter-over-needle form as other legally marketed devices.
The AngioXpand Introducer Catheter decreases the range of introducing needle sizes required during patient cannulation. The system is expected to provide a patient the benefit realized by decreasing the size of the introducing needle required of larger gauge introducers.
An appropriate sized guidewire or dilator becomes the means of expanding the introducer's tip, allowing passage of a catheter or guidewire into the blood vessel. This action permits the initial size of the needle to be smaller than the desired placed catheter size.
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