Cleared Special

NUVISION? Ultrasound Catheter; NUVISION? NAV Ultrasound Catheter

K241540 · Biosense Webster, Inc. · Cardiovascular
Jun 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241540 is an FDA 510(k) clearance for the NUVISION? Ultrasound Catheter; NUVISION? NAV 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 28, 2024, 28 days after receiving the submission on May 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K241540 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date June 28, 2024
Days to Decision 28 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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