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510(k) K212047

Pantheris System by Avinger, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2021
Date Received
June 30, 2021
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.

  • K230005 — Pantheris LV Atherectomy Catheter (June 6, 2023)
  • K230594 — Tigereye ST CTO-Crossing Catheter (April 25, 2023)
  • K212468 — Tigereye CTO-Crossing Catheter (January 6, 2022)
  • 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)

Other clearances for product code MCW

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  • K250385 — Turbo-Elite Laser Atherectomy Catheter (March 13, 2025)
  • K242757 — Rotarex Atherectomy System (January 30, 2025)
  • K242947 — FreedomFlow™ Orbital Circumferential Atherectomy System (November 5, 2024)
  • K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophili (June 27, 2024)
  • 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)
  • K230005 — Pantheris LV Atherectomy Catheter (June 6, 2023)