SWAN-GANZ FLOW-DIRECTED THERMODILUTION

Catheter, Flow Directed

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Swan-ganz Flow-directed Thermodilution.

Pre-market Notification Details

Device IDK810352
510k NumberK810352
Device Name:SWAN-GANZ FLOW-DIRECTED THERMODILUTION
ClassificationCatheter, Flow Directed
Applicant AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-10
Decision Date1981-03-27

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