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510(k) Data Aggregation
Manufacturer
Date Cleared
2025-11-26
(118 days)
Product Code
Regulation Number
870.1220Type
TraditionalPanel
CardiovascularReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
Device Description
The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic Tip Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
AI/ML Overview
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