Cleared Traditional

K131914 - OFFROAD RE-ENTRY CATHETER SYSTEM

K131914 is the FDA 510(k) clearance for OFFROAD RE-ENTRY CATHETER SYSTEM by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K131914 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
127d
Days
Class 2
Risk

K131914 is an FDA 510(k) clearance for the OFFROAD RE-ENTRY CATHETER SYSTEM. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 127 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 Boston Scientific Corp devices

Submission Details

510(k) Number K131914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date October 31, 2013
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT01500031 Completed Interventional Industry-sponsored

Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

92
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Chronic Total Occlusion
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Andrej Schmidt
Sponsor Boston Scientific Corporation (industry)
Started 2012-04-01 → Primary completion 2013-04-01 → Completed 2013-05-01
Primary outcome
Composite Rate of Major Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 23
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K131914.
SoundBite Console, SoundBite Active Wire 18
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XableCath Crossing Catheter
K183357 · Xablecath, Inc. · Jan 2019
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014
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