SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

Catheter, Intravascular, Diagnostic

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz(r) Hi-shore(r) Thermo Cath W/amc(tm).

Pre-market Notification Details

Device IDK910204
510k NumberK910204
Device Name:SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
ClassificationCatheter, Intravascular, Diagnostic
Applicant BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
ContactNancly E Shadforth
CorrespondentNancly 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 Received1991-01-16
Decision Date1991-04-24

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