ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

Catheter, Ultrasound, Intravascular

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acunav Diagnostic Ultrasound Catheter 8f And 10f.

Pre-market Notification Details

Device IDK071234
510k NumberK071234
Device Name:ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
ClassificationCatheter, Ultrasound, Intravascular
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
ContactSheila W Pickering
CorrespondentSheila W Pickering
SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-03
Decision Date2007-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869001043 K071234 000
04056869001036 K071234 000
04056869001029 K071234 000
04056869001012 K071234 000

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