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K Number
K011557
Device Name
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
Manufacturer
NUMED, INC.
Date Cleared
2001-07-12

(52 days)

Product Code
DXF,DQO,LIT
Regulation Number
870.5175
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).