FDA.reportPublic FDA data

ACCLARENT, INC.

Matched from indexed company URL: Acclarent, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051727593005172759ACCLARENT, INC.1Y2026-01-017585 Irvine Center Dr Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10705031063549RELIEVA SIDEKICK LP - RELIEVA SIDEKICK SINUS GUIDE HANDLE LOW PROFILE+1(800)654-2873custsvcnj@integralife.com
10705031200258RELIEVA ULTIRRA - RELIEVA ULTIRRA SINUS BALLOON CATHETER 5x16+1(800)654-2873custsvcnj@integralife.com
10705031200272RELIEVA ULTIRRA - RELIEVA ULTIRRA SINUS BALLOON CATHETER 6x16+1(800)654-2873custsvcnj@integralife.com
10705031200289RELIEVA ULTIRRA - RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x16+1(800)654-2873custsvcnj@integralife.com
10705031200296RELIEVA ULTIRRA - RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x24+1(800)654-2873custsvcnj@integralife.com
10705031205871RELIEVA VORTEX 2 - RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER+1(800)654-2873custsvcnj@integralife.com
10705031237087ACCLARENT NAVWIRE - ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE+1(800)654-2873custsvcnj@integralife.com
10705031238701RELIEVA ULTIRRA NAV - RELIEVA ULTIRRA NAV SINUS BALLOON CATHETER, 5x16MM+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1893292003218006K231862TruDi® Navigation System V3 (FG-2000-00)PGW2023-07-21
1893291651502895K221037TruDi Shaver BladePGW2022-07-20
1893291809228554K201174TruDi CurettePGW2020-08-12
1893291678866566K201115Next Generation Balloon Dilation SystemLRC2020-08-27
1893291512231997K193453TruDi ProbePGW2020-03-23
1893291976742903K192397TruDi Navigation SystemPGW2020-01-30
1893291248692526K190532TruDi NAV WirePGW2019-05-03
1893291471479519K190525RELIEVA ULTIRRA Sinus Balloon CatheterLRC2019-05-03
1893291215296081K183090Relieva Tract Balloon Dilation SystemQGK2019-04-19
1893291716953607K180948TruDi NAV Suction InstrumentsPGW2018-07-20
1893291233877602K173628Acclarent ENT Navigation SystemPGW2018-03-10
1893291829810275K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC2017-09-05
1893291382675912K161701CARTO ENT SystemPGW2016-10-24
1893292043377137K161698Relieva UltirraNav Sinus Balloon CatheterLRC2016-10-24
1893291462703040K161697Acclarent NavWire Sinus Navigation GuidewirePGW2016-10-24
1893291083421682K153341Relieva Scout Multi-Sinus Dilation SystemLRC2016-02-12
1893291024463194K150172ACCLARENT SE Inflation DeviceLRC2015-04-07
1893291614255072K143541Relieva SpinPlus Balloon Sinuplasty SystemLRC2015-04-22
1893291734136692K111875RELIEVA SPIN SINUS DILATION SYSTEMLRC2011-10-11
1893292073238022K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETERLRC2011-08-22
1893291476713565K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEEOB2011-05-27
1893292029292101K090660AIRWAY BALLOON CATHETER INFLATION DEVICEKTI2009-06-12
1893291882199561K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AKAM2007-09-28
1893291484854148K052198RELIEVA SINUS BALLOON INFLATION DEVICELRC2005-08-31
1893291873703057DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemPNZ2016-09-16
1893291022186907
1893291260983991
1893291433471143
1893291593857167

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PGW102023-07-21
LRC102020-08-27
QGK12019-04-19
PNZ12016-09-16
EOB12011-05-27
KTI12009-06-12
KAM12007-09-28

PMN#

43 records. Showing 1-40. Next

GUDID#

192 records. Showing 1-40. Next