Cleared Traditional

Tigereye CTO-Crossing Catheter

K201330 · Avinger, Inc. · Cardiovascular

Sep 2020

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K201330 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 September 10, 2020, 114 days after receiving the submission on May 19, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K201330 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2020
Decision Date	September 10, 2020
Days to Decision	114 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.