K Number
K131869Device Name
PTS-X SIZING BALLOON CATHETERManufacturer
Date Cleared
2013-08-08
(45 days)
Product Code
Regulation Number
870.4450Type
SpecialPanel
CVReference & 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).