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510(k) Data Aggregation
K Number
K213492Device Name
Dib UltraNav Transseptal Catheter System
Manufacturer
Date Cleared
2022-03-24
(143 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Dib UltraNav Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dib UltraNav Transseptal Catheter System is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal puncture.
Device Description
The Dib UltraNav Transseptal Catheter System is a single-use, dual lumen, non-steerable intravascular catheter and handle to be used during a percutaneous procedure to support visualization and puncture of the septum. It is to be used to cross the interatrial septum and enable placement of a guidewire into the left side of the heart. The UltraNav catheter system is used with off-the-shelf transseptal needles and ultrasound catheters (not provided).
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