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510(k) Data Aggregation
K Number
K013136Device Name
ANEURYSM CLIPS
Manufacturer
Date Cleared
2001-11-26
(68 days)
Product Code
Regulation Number
882.5200Why did this record match?
Applicant Name (Manufacturer) :
GISTLSTRASSE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perneczky Titanium Aneurysm Clips are devices used to occlude an intracranial aneurysm (a balloon like Sac formed on a blood vessel) to prevent it from bleeding or rebleeding. These clips are intended for use as temporary or permanent devices.
Device Description
These titanium alloy aneurysm clips will be available as temporary or permanent in STANDARD OR MINI/ MICRO models.
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