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K Number
K001063
Device Name
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
2000-07-07

(95 days)

Product Code
DYG
Regulation Number
870.1240
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1240 Flow-directed catheter.

(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).