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510(k) Data Aggregation
K Number
K974617Device Name
PERIPHERAL VASCULAR DILATOR
Manufacturer
Date Cleared
1998-12-01
(355 days)
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
ENDOVASCULAR INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.
Device Description
The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure. The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.
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