Cleared Special

SoundBite Crossing System - Peripheral (14P)

K210839 · Soundbite Medical Solutions, Inc. · Cardiovascular

Apr 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K210839 is an FDA 510(k) clearance for the SoundBite Crossing System - Peripheral (14P), a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Soundbite Medical Solutions, Inc. (Montreal, CA). The FDA issued a Cleared decision on April 20, 2021, 29 days after receiving the submission on March 22, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K210839 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2021
Decision Date	April 20, 2021
Days to Decision	29 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.