Cleared Traditional

K150187 - ELITECROSS Support Catheter

K150187 is an FDA 510(k) clearance for ELITECROSS Support Catheter, manufactured by Cordis Corporation, A Johnson & Johnson Company. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K150187 · Cordis Corporation, A Johnson & Johnson Company · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
112d
Days
Class 2
Risk

K150187 is an FDA 510(k) clearance for the ELITECROSS Support Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Cordis Corporation, A Johnson & Johnson Company (Fremont, US). The FDA issued a Cleared decision on May 19, 2015 after a review of 112 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.

FDA 510(k) Submission Details - K150187

510(k) Number K150187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date May 19, 2015
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K150187.
RA-308 Excimer Laser System, Excimer Laser Catheter
K170349 · Ra Medical Systems,Inc · May 2017
Pioneer Plus Catheter
K162418 · Philips Volcano · Dec 2016
CROSSER CTO Recanalization Catheter
K161208 · Bard Peripheral Vacular, Inc. · May 2016
OUTBACK Elite Re-Entry Catheter
K150836 · Cordis Corporation, A Johnson & Johnson Co. · Apr 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