Cleared Special

VersaCross? RF Wire

K242076 · Baylis Medical Company · Cardiovascular
Nov 2024
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K242076 is an FDA 510(k) clearance for the VersaCross? RF Wire, a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Baylis Medical Company (Mississauga, CA). The FDA issued a Cleared decision on November 1, 2024, 108 days after receiving the submission on July 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K242076 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2024
Decision Date November 01, 2024
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

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