Cleared Special

K123532 - OCELOT PIXL CATHETER
(FDA 510(k) Clearance)

K123532 · Avinger, Inc. · Cardiovascular

Dec 2012

Decision

28d

Days

Class 2

Risk

K123532 is an FDA 510(k) clearance for the OCELOT PIXL 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 December 14, 2012, 28 days after receiving the submission on November 16, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K123532 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2012
Decision Date	December 14, 2012
Days to Decision	28 days
Submission Type	Special
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.