ISOFLO(TM) HIGH PRESSURE INJECTION LINES

Injector And Syringe, Angiographic

HEALTHDYNE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Healthdyne Cardiovascular, Inc. with the FDA for Isoflo(tm) High Pressure Injection Lines.

Pre-market Notification Details

Device IDK901382
510k NumberK901382
Device Name:ISOFLO(TM) HIGH PRESSURE INJECTION LINES
ClassificationInjector And Syringe, Angiographic
Applicant HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine,  CA  92618 -1658
ContactBill Welch
CorrespondentBill Welch
HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine,  CA  92618 -1658
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-22
Decision Date1990-07-19

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