ACCLARENT AERA Eustachian Tube Dilation System
Acclarent, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005172759 | 3005172759 | ACCLARENT, INC. | 1 | Y | 2026-01-01 | 7585 Irvine Center Dr Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10705031147744 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 16x40 | +1(800)654-2873 | custsvcnj@integralife.com |
| 10705031206052 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 8.5x24 | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031063089 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 5x24, 1 PK | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031063126 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 7x24, 1 PK | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031063157 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031063171 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM 14x40, 1 PK | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031147703 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM, 12X40MM - 1 PK | +1(800)654-2873 | custsvcnj@integralife.com |
| 20705031242682 | INSPIRA AIR - INSPIRA AIR BALLOON DILATION SYSTEM, 8.5X24MM - 1PK | +1(800)654-2873 | custsvcnj@integralife.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 189329 | 1433128789 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | 2026-02-19 |
| 189329 | 2003218006 | K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | 2023-07-21 |
| 189329 | 1651502895 | K221037 | TruDi Shaver Blade | PGW | 2022-07-20 |
| 189329 | 1809228554 | K201174 | TruDi Curette | PGW | 2020-08-12 |
| 189329 | 1678866566 | K201115 | Next Generation Balloon Dilation System | LRC | 2020-08-27 |
| 189329 | 1512231997 | K193453 | TruDi Probe | PGW | 2020-03-23 |
| 189329 | 1976742903 | K192397 | TruDi Navigation System | PGW | 2020-01-30 |
| 189329 | 1248692526 | K190532 | TruDi NAV Wire | PGW | 2019-05-03 |
| 189329 | 1471479519 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | 2019-05-03 |
| 189329 | 1215296081 | K183090 | Relieva Tract Balloon Dilation System | QGK | 2019-04-19 |
| 189329 | 1716953607 | K180948 | TruDi NAV Suction Instruments | PGW | 2018-07-20 |
| 189329 | 1233877602 | K173628 | Acclarent ENT Navigation System | PGW | 2018-03-10 |
| 189329 | 1829810275 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | 2017-09-05 |
| 189329 | 1382675912 | K161701 | CARTO ENT System | PGW | 2016-10-24 |
| 189329 | 2043377137 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | LRC | 2016-10-24 |
| 189329 | 1462703040 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | PGW | 2016-10-24 |
| 189329 | 1083421682 | K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | 2016-02-12 |
| 189329 | 1024463194 | K150172 | ACCLARENT SE Inflation Device | LRC | 2015-04-07 |
| 189329 | 1614255072 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | LRC | 2015-04-22 |
| 189329 | 1734136692 | K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | LRC | 2011-10-11 |
| 189329 | 2073238022 | K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | LRC | 2011-08-22 |
| 189329 | 2016414282 | K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | KTI | 2011-03-31 |
| 189329 | 1476713565 | K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | EOB | 2011-05-27 |
| 189329 | 2029292101 | K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | KTI | 2009-06-12 |
| 189329 | 1882199561 | K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | KAM | 2007-09-28 |
| 189329 | 1484854148 | K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | LRC | 2005-08-31 |
| 189329 | 1873703057 | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | PNZ | 2016-09-16 |
| 189329 | 1022186907 | ||||
| 189329 | 1260983991 | ||||
| 189329 | 1433471143 | ||||
| 189329 | 1593857167 |
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc.
Acclarent, Inc
Acclarent, Inc.
Acclarent, Inc.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
ACCLARENT, INC.
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