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510(k) Data Aggregation
K Number
K984482Device Name
AVE GL-1 GUIDING CATHETER
Date Cleared
1999-07-30
(226 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.
Device Description
The GL-1 catheter is a guiding catheter for use in the vascular system. Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced. Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.
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