Cleared Traditional

Steerable catheter control system

K183027 · Stereotaxis, Inc. · Cardiovascular
Sep 2019
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K183027 is an FDA 510(k) clearance for the Steerable catheter control system, a Catheter Remote Control System (Class II — Special Controls, product code PJB), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 6, 2019, 309 days after receiving the submission on November 1, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5700.

Submission Details

510(k) Number K183027 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2018
Decision Date September 06, 2019
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PJB — Catheter Remote Control System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5700
Definition A Steerable Cardiac Ablation Catheter Remote Control System Is A Device That Is External To The Body And Interacts With The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control The Advancement, Retraction, Rotation, And Deflection Of A Steerable Ablation Catheter Used For The Treatment Of Cardiac Arrhythmias In The Right Side Of The Heart. The Device Allows Reversion To Manual Control Of The Steerable Cardiac Ablation Catheter Without Withdrawal Of The Catheter And Interruption Of The Procedure.