510(k) K111254
- Device
- RELIEVA SOLO ELITE SINUS BALLOON CATHETER
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K111254
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-22
- Date received
- 2011-05-04
- Regulation
- 874.4420
- Classification name
- Instrument, Ent Manual Surgical
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIM KY
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers#
- 3006405073
- 1834331
- 2031917
- 8010617
- 8010298
- 8043752
- 3007583964
- 3010149039
- 3018094310
- 3002807315
- 3007689689
- 3045853999
- 8043441
- 3015451162
- 3001084743
- 1043729
- 3006154292
- 9613646
- 3030839824
- 3014615697
- 3003836856
- 8010257
- 9617426
- 3003790304
- 3012964172
- 3012267976
- 3009092818
- 9710014
- 3027828125
- 2183319
- 8010177
- 2183570
- 3005216725
- 3014579188
- 8043769
- 1037007
- 3011596340
- 3014201171
- 1825146
- 3001614464
- 3013247477
- 1045254
- 3002858762
- 1720747
- 1219653
- 3002834291
- 3005900820
- 1923569
- 1057946
- 8010282
- 3004450489
- 9680515
- 3007137643
- 3012995405
- 9615001
- 1649518
- 1123010
- 9681147
- 3008770252
- 9610773
- 3006554912
- 9610612
- 1064858
- 3013528571
- 9611262
- 3030516433
- 1056350
- 3006345872
- 3007738736
- 1219795
- 3011310592
- 3007225047
- 3006546082
- 9613926
- 1932180
- 1061927
- 3003644849
- 3012167431
- 9680837
- 3013840437
Source Documents#
Other 510(k) Records For Product Code LRC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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