Cleared Traditional

SoundBite? Crossing System XS Peripheral

K230159 · Soundbite Medical Solutions, Inc. · Cardiovascular

Aug 2023

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K230159 is an FDA 510(k) clearance for the SoundBite? Crossing System XS Peripheral, 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 August 28, 2023, 221 days after receiving the submission on January 19, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K230159 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2023
Decision Date	August 28, 2023
Days to Decision	221 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.