Cleared Special

Rotarex Atherectomy System

K242757 · Bard Peripheral Vascular, Inc. · Cardiovascular
Jan 2025
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K242757 is an FDA 510(k) clearance for the Rotarex Atherectomy System, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on January 30, 2025, 140 days after receiving the submission on September 12, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K242757 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2024
Decision Date January 30, 2025
Days to Decision 140 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MCW — Catheter, Peripheral, Atherectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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