510(k) K143541
- Device
- Relieva SpinPlus Balloon Sinuplasty System
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K143541
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-22
- Date received
- 2014-12-15
- 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
- Pavan Sethi
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers#
- 8010510
- 9613083
- 3009018440
- 2135225
- 3002834291
- 3007583964
- 1225984
- 3005440795
- 9611112
- 3010707607
- 3005900820
- 3012995405
- 3013846070
- 9613646
- 3008843439
- 1057946
- 1834331
- 3004450489
- 3003761012
- 1926681
- 1057421
- 3004215117
- 1045254
- 8010433
- 3008729892
- 3005528784
- 3015718821
- 3003678543
- 9616024
- 9710524
- 3008338766
- 3010269591
- 3011050570
- 9615004
- 3007137643
- 1412854
- 3011596340
- 1825146
- 1649518
- 3003418325
- 1811755
- 3013840437
- 8010523
- 3015451162
- 3042895342
- 9611102
- 3025961941
- 3030516433
- 8020785
- 9610617
- 3008280196
- 3008388245
- 1646831
- 3013247477
- 3012226300
- 3017166758
- 1047843
- 3035708926
- 9610905
- 3042278955
- 1421879
- 1057358
- 3013528571
- 3018094310
- 3002858762
- 3003836856
- 3004530184
- 1018470
- 1061927
- 1056350
- 3010455030
- 3014345718
- 3014201171
- 9611262
- 3014334038
- 3005216725
- 9613926
- 3012507533
- 3016069968
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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