SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

Catheter, Continuous Flush

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz Intellicath Cco Thermodilution Catheter.

Pre-market Notification Details

Device IDK924661
510k NumberK924661
Device Name:SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
ClassificationCatheter, Continuous Flush
Applicant BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
ContactFoss Davies
CorrespondentFoss Davies
BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-15
Decision Date1993-04-08

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