INSPIRA AIR BALLOON DILATION SYSTEM


Device Classification Name

bronchoscope accessory

510(k) Number K110218
Device Name INSPIRA AIR BALLOON DILATION SYSTEM
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Applicant Contact keri yen
Correspondent
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Correspodent Contact keri yen
Regulation Number 874.4680
Classification Product Code
KTI  
Date Received 01/25/2011
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls