Cleared Traditional

K122380 - OCELOT SYSTEM
(FDA 510(k) Clearance)

K122380 · Avinger, Inc. · Cardiovascular

Nov 2012

Decision

93d

Days

Class 2

Risk

K122380 is an FDA 510(k) clearance for the OCELOT SYSTEM. This device is classified as 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 November 7, 2012, 93 days after receiving the submission on August 6, 2012.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. 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..

Submission Details

510(k) Number	K122380 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2012
Decision Date	November 07, 2012
Days to Decision	93 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.