Cleared Special

SOUNDSTAR? CRYSTAL Ultrasound Catheter

K240050 · Biosense Webster, Inc. · Cardiovascular
Jun 2024
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K240050 is an FDA 510(k) clearance for the SOUNDSTAR? CRYSTAL Ultrasound Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on June 12, 2024, 156 days after receiving the submission on January 8, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K240050 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2024
Decision Date June 12, 2024
Days to Decision 156 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OBJ — Catheter, Ultrasound, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.

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