RELIEVA SOLO ELITE SINUS BALLOON CATHETER

Instrument, Ent Manual Surgical

ACCLARENT, INC.

The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Solo Elite Sinus Balloon Catheter.

Pre-market Notification Details

Device IDK111254
510k NumberK111254
Device Name:RELIEVA SOLO ELITE SINUS BALLOON CATHETER
ClassificationInstrument, Ent Manual Surgical
Applicant ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
ContactKim Ky
CorrespondentKim Ky
ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-04
Decision Date2011-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705031200293 K111254 000
20705031200286 K111254 000
20705031200279 K111254 000
20705031200255 K111254 000

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