Cleared Traditional

Tigereye CTO-Crossing Catheter

K212468 · Avinger, Inc. · Cardiovascular

Jan 2022

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K212468 is an FDA 510(k) clearance for the Tigereye CTO-Crossing Catheter, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 6, 2022, 153 days after receiving the submission on August 6, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K212468 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2021
Decision Date	January 06, 2022
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	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.