K183027 is an FDA 510(k) clearance for the Steerable catheter control system. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.5700. 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..
| 510(k) Number | K183027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |