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K Number
K243795
Device Name
pREBOA-PRO Catheter
Manufacturer
Prytime Medical Devices, Inc.
Date Cleared
2025-09-05

(269 days)

Product Code
MJN
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).