MODIFIED FLOCATH PULMONARY ARTERY CATHETER

Flowmeter, Blood, Cardiovascular

CARDIOMETRICS, INC.

The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Modified Flocath Pulmonary Artery Catheter.

Pre-market Notification Details

Device IDK901733
510k NumberK901733
Device Name:MODIFIED FLOCATH PULMONARY ARTERY CATHETER
ClassificationFlowmeter, Blood, Cardiovascular
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactMichael J Billig
CorrespondentMichael J Billig
CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-17
Decision Date1990-07-16

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