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510(k) Data Aggregation
K Number
K192998Device Name
Reprocessed BRK Transseptal Needle
Manufacturer
Date Cleared
2020-07-22
(268 days)
Product Code
Regulation Number
870.1390Why did this record match?
Product Code :
NMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reprocessed BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Device Description
The reprocessed BRK Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical transseptal introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of a St. Jude Medical transseptal introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and/or guidewire insertion (0.014" maximum guidewire diameter for an 18 gauge needle). The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within the dilator. The reprocessed needle is available in various useable lengths and distal curve configurations.
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