Cleared Traditional

K122380 - OCELOT SYSTEM

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

K122380 · Avinger, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K122380

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

PDU Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01537302 Completed Interventional Industry-sponsored

Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

100
Patients (actual)
17
Sites
Treatment
Purpose
Open label
Masking
Condition studied Total Atherosclerotic Occlusion of Femoral Artery
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Matthew Selmon, MD
Sponsor Avinger, Inc. (industry)
Started 2012-02-01 → Primary completion 2012-06-01
Primary outcome
Primary Safety Endpoint
Secondary outcome
Procedural Success
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 49
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K122380.
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013
OCELOT PIXL CATHETER
K123532 · Avinger, Inc. · Dec 2012
OCELOT CATHETER
K123462 · Avinger, Inc. · Dec 2012
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K120533 · Bridgepoint Medical · May 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · Avinger, Inc. · Mar 2012
WILDCAT CATHETER
K113838 · Avinger, Inc. · Mar 2012