Cleared Traditional

OFFROAD RE-ENTRY CATHETER SYSTEM

K131914 · Boston Scientific Corp · Cardiovascular

Oct 2013

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K131914 is an FDA 510(k) clearance for the OFFROAD RE-ENTRY CATHETER SYSTEM, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 31, 2013, 127 days after receiving the submission on June 26, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K131914 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — 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.