VIVAWAVE MICROWAVE SYSTEM

System, Ablation, Microwave And Accessories

VIVANT MEDICAL, INC.

The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivawave Microwave System.

Pre-market Notification Details

Device IDK011676
510k NumberK011676
Device Name:VIVAWAVE MICROWAVE SYSTEM
ClassificationSystem, Ablation, Microwave And Accessories
Applicant VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View,  CA  94043
ContactSteven Kim
CorrespondentSteven Kim
VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View,  CA  94043
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-30
Decision Date2002-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884524002538 K011676 000
10884524001722 K011676 000
10884524002583 K011676 000
10884524001579 K011676 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.