ACCLARENT

FDA Registration(s)

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

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
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	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