CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER

Transducer, Pressure, Catheter Tip

ACIST MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Cardiovascular Pressure Measurement (cpm) System, Navvus Catheter.

Pre-market Notification Details

Device IDK132474
510k NumberK132474
Device Name:CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
ClassificationTransducer, Pressure, Catheter Tip
Applicant ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie,  MN  55344
ContactMatthew Stepanek
CorrespondentMatthew Stepanek
ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie,  MN  55344
Product CodeDXO  
CFR Regulation Number870.2870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-07
Decision Date2014-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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