FLOW DIRECTED THERMAL-DILUTION INFUSION

K821057 · Oximetrix, Inc. · DYG · May 18, 1982 · Cardiovascular

Device Facts

Record IDK821057
Device NameFLOW DIRECTED THERMAL-DILUTION INFUSION
ApplicantOximetrix, Inc.
Product CodeDYG · Cardiovascular
Decision DateMay 18, 1982
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1240
Device ClassClass 2

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Innolitics

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