Cleared Traditional

KITTYCAT CATHETER, KITTYCAT 2 CATHETER

K120273 · Avinger, Inc. · Cardiovascular

Mar 2012

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K120273 is an FDA 510(k) clearance for the KITTYCAT CATHETER, KITTYCAT 2 CATHETER, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Avinger, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 30, 2012, 60 days after receiving the submission on January 30, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K120273 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2012
Decision Date	March 30, 2012
Days to Decision	60 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.