Cleared Traditional

Tunnel Crossing Catheter

K221163 · Tractus Vascular, LLC · Cardiovascular

Jan 2023

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K221163 is an FDA 510(k) clearance for the Tunnel Crossing Catheter, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Tractus Vascular, LLC (Eatontown, US). The FDA issued a Cleared decision on January 19, 2023, 272 days after receiving the submission on April 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K221163 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2022
Decision Date	January 19, 2023
Days to Decision	272 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.