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510(k) Data Aggregation
K Number
K960372Device Name
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
Manufacturer
Date Cleared
1996-04-26
(91 days)
Product Code
Regulation Number
882.5200Why did this record match?
Applicant Name (Manufacturer) :
SCANLAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting.
Device Description
The SCANLAN® Heifetz Aneurysm Elgiloy Clip System is a device used to occlude an intractanial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A. ) A schematic for a representative clip size is provided in Appendix B.
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