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510(k) K230005

Pantheris LV Atherectomy Catheter by Avinger, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2023
Date Received
January 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Avinger, Inc.

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  • K212047 — Pantheris System (November 16, 2021)
  • K201330 — Tigereye CTO-Crossing Catheter (September 10, 2020)
  • K182341 — Pantheris SV (April 9, 2019)
  • K173862 — Pantheris System (May 22, 2018)
  • K172236 — Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, L (October 30, 2017)
  • K163264 — Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lig (December 21, 2016)
  • K162326 — Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (October 18, 2016)
  • K160827 — Pantheris Catheter (April 21, 2016)

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  • K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi (February 15, 2024)
  • K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Aury (December 15, 2023)
  • K231538 — FreedomFlow Orbital Circumferential Atherectomy System (September 27, 2023)
  • K230709 — Auryon Atherectomy System (June 9, 2023)
  • K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (December 8, 2022)