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K Number
K252569
Device Name
Carrier XL Delivery Catheter
Manufacturer
Balt USA, LLC
Date Cleared
2025-10-22

(69 days)

Product Code
QJP
Regulation Number
870.1250
Type
Special
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).