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K Number
K002627
Device Name
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2001-04-26

(246 days)

Product Code
DXE
Regulation Number
870.5150
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).