Next Generation Balloon Dilation System

Instrument, Ent Manual Surgical

Acclarent Inc.

The following data is part of a premarket notification filed by Acclarent Inc. with the FDA for Next Generation Balloon Dilation System.

Pre-market Notification Details

Device IDK201115
510k NumberK201115
Device Name:Next Generation Balloon Dilation System
ClassificationInstrument, Ent Manual Surgical
Applicant Acclarent Inc. 31 Technology Dr., Suite 200 Irvine,  CA  92618
ContactDavid Locke
CorrespondentDavid Locke
Acclarent Inc. 31 Technology Dr., Suite 200 Irvine,  CA  92618
Product CodeLRC  
Subsequent Product CodePGW
Subsequent Product CodePNZ
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2020-08-27

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.