CAAS A-Valve

System, Image Processing, Radiological

PIE MEDICAL IMAGING B.V.

The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas A-valve.

Pre-market Notification Details

Device IDK143044
510k NumberK143044
Device Name:CAAS A-Valve
ClassificationSystem, Image Processing, Radiological
Applicant PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht,  NL 6227 Aj
ContactFlorie Daniels
CorrespondentFlorie Daniels
PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht,  NL 6227 Aj
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-22
Decision Date2015-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304451156 K143044 000
08056304454270 K143044 000

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