Cleared Traditional

K122380 - OCELOT SYSTEM

K122380 is the FDA 510(k) clearance for OCELOT SYSTEM by Avinger, Inc.. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K122380 · Avinger, Inc. · Cardiovascular device
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Nov 2012
Decision
93d
Days
Class 2
Risk

K122380 is an FDA 510(k) clearance for the OCELOT SYSTEM. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 7, 2012 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Avinger, Inc. devices

Submission Details

510(k) Number K122380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 24
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K122380.
XableCath Crossing Catheter
K183357 · Xablecath, Inc. · Jan 2019
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · Medtronic Vascular · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008