Cleared Special

K150836 - OUTBACK Elite Re-Entry Catheter

K150836 is an FDA 510(k) clearance for OUTBACK Elite Re-Entry Catheter, manufactured by Cordis Corporation, A Johnson & Johnson Co.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Special 510(k) pathway after a 30-day FDA review.

K150836 · Cordis Corporation, A Johnson & Johnson Co. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
30d
Days
Class 2
Risk

K150836 is an FDA 510(k) clearance for the OUTBACK Elite Re-Entry Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Cordis Corporation, A Johnson & Johnson Co. (Fremont, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150836

510(k) Number K150836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2015
Decision Date April 29, 2015
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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. 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 57
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K150836.
Pioneer Plus Catheter
K162418 · Philips Volcano · Dec 2016
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K161208 · Bard Peripheral Vacular, Inc. · May 2016
ELITECROSS Support Catheter
K150187 · Cordis Corporation, A Johnson & Johnson Company · May 2015
MICRO GUIDE CATHETER ELITE
K140438 · Cordis Corp., A Johnson & Johnson Co. · Nov 2014
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · Avinger, Inc. · May 2014
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014