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K Number
K250960
Device Name
DUO Microcatheter
Manufacturer
REV Neuro LLC
Date Cleared
2025-09-08

(161 days)

Product Code
QJP,DQO,DQY
Regulation Number
870.1250
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).