INSPIRA AIR BALLOON DILATION SYSTEM

Bronchoscope Accessory

ACCLARENT, INC.

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

Pre-market Notification Details

Device IDK110218
510k NumberK110218
Device Name:INSPIRA AIR BALLOON DILATION SYSTEM
ClassificationBronchoscope Accessory
Applicant ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
ContactKeri Yen
CorrespondentKeri Yen
ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
Product CodeKTI  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-25
Decision Date2011-03-31
Summary:summary

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