AVAflex Vertebral Balloon System

Arthroscope

CAREFUSION

The following data is part of a premarket notification filed by Carefusion with the FDA for Avaflex Vertebral Balloon System.

Pre-market Notification Details

Device IDK151125
510k NumberK151125
Device Name:AVAflex Vertebral Balloon System
ClassificationArthroscope
Applicant CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills,  IL  60061
ContactJoy Greidanus
CorrespondentJoy Greidanus
CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills,  IL  60061
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-28
Decision Date2015-11-24
Summary:summary

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