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510(k) Data Aggregation
Device Name
Peel-Away Introducer SheathManufacturer
Date Cleared
2026-02-09
(42 days)
Product Code
Regulation Number
870.1340Type
TraditionalPanel
CardiovascularAge Range
18 - 150
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Peel-Away Introducer Sheath is intended for the percutaneous introduction of catheters and other intravascular devices into the vasculature.
Device Description
The subject device Peel-Away Introducer Sheath is substantially equivalent to the predicate device Tear Away Introducer Sheath cleared under K153533. Both the subject device and the predicate device introduce catheters and other intravascular devices into the vasculature percutaneously. Evaluation of the technology characteristics demonstrates that the subject device is substantially equivalent to the predicate device. The subject device does not give rise to any new safety or performance questions.
AI/ML Overview
N/A
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