Cleared Special

TRUEPATH CTO DEVICE

K140288 · Boston Scientific Corp · Cardiovascular

Apr 2014

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K140288 is an FDA 510(k) clearance for the TRUEPATH CTO DEVICE, 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 April 16, 2014, 70 days after receiving the submission on February 5, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K140288 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2014
Decision Date	April 16, 2014
Days to Decision	70 days
Submission Type	Special
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.