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510(k) K212468

Tigereye CTO-Crossing Catheter by Avinger, Inc. — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2022
Date Received
August 6, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter For Crossing Total Occlusions
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Other clearances by Avinger, Inc.

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  • K201330 — Tigereye CTO-Crossing Catheter (September 10, 2020)
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  • 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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