SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

• 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: Cardiovascular
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K041739 , K160084

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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).