PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH

Catheter, Intravascular, Diagnostic

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Pulmonary Artery Flow-directed Thermodilution Cath.

Pre-market Notification Details

Device IDK915726
510k NumberK915726
Device Name:PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
ClassificationCatheter, Intravascular, Diagnostic
Applicant BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
ContactNancy E Shadforth
CorrespondentNancy E Shadforth
BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-20
Decision Date1992-09-21

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