FDA 510(k) Premarket Notification K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System

Submission Details & Decision

Normalized public record details for 510(k) notification K171761.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171761

Applicant / Sponsor

Acclarent, Inc.

Device Name

ACCLARENT AERA Eustachian Tube Balloon Dilation System

Product Code

PNZ

Decision Date

2018-01-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-06-14

Related Establishments / Registrations

MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
BIOMERICS FMI Registration: 1646831 View Registration
STRYKER CORP. Registration: 1811755 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
SPIGGLE & THEIS MEDIZINTECHNIK GMBH Registration: 3002858762 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
Biomerics Alajuela Registration: 3003678543 View Registration
ACCLARENT, INC. Registration: 3005172759 View Registration
Mentor Texas LP Registration: 3005423519 View Registration
HEMOSTASIS, LLC Registration: 3007225047 View Registration
GEODIS Registration: 3008087383 View Registration
Nitinol Devices & Components Costa Rica, S. R. L. Registration: 3009018440 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
Fiagon GMBH Registration: 3010313588 View Registration
Stryker Instruments Registration: 3015967359 View Registration
MIDWEST INTERVENTIONAL SYSTEMS Registration: 3016842760 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration

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