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510(k) K161698

Relieva UltirraNav Sinus Balloon Catheter by Acclarent, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2016
Date Received
June 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Acclarent, Inc.

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  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K183090 — Relieva Tract Balloon Dilation System (April 19, 2019)

Other clearances for product code LRC

  • K230258 — BB 8 Sinus Dilation Kit (May 25, 2023)
  • K212774 — VenSure LightGuide (February 4, 2022)
  • K201398 — SINUSPRIME Dilation System (October 15, 2020)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K181546 — Dillard Nasal Balloon Catheter (January 3, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K181838 — Sinusway Dilation System (December 20, 2018)
  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)