Steerable Catheter Control System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183027 FDA 510(k)
- FDA Product Code
- PJB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5700 FDA 510(k)
- Regulation Number
- 870.5700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Steerable Catheter Control System is a device designed for controlling catheters during cardiovascular procedures. It provides precision and stability when navigating catheters through the cardiovascular system.
This system is supplied by Stereotaxis, Inc. and is authorized under FDA 510(k) clearance with product code PJB. It is intended for use in cardiovascular procedures and is part of a portfolio that includes robotic magnetic navigation systems and mapping catheters.
Frequently asked questions
What is the Steerable Catheter Control System used for?
The Steerable Catheter Control System is designed for controlling catheters during cardiovascular procedures. It provides precision and stability when navigating catheters through the cardiovascular system, assisting clinicians in complex interventions.
How is the Steerable Catheter Control System supplied?
The system is supplied by Stereotaxis, Inc. and is part of a portfolio that includes robotic magnetic navigation systems and mapping catheters. It is intended for use in cardiovascular procedures requiring precise catheter control.
What is the regulatory status of this device?
The Steerable Catheter Control System is authorized under FDA 510(k) clearance with product code PJB. It received clearance in 2019 and is classified as a Class II device for cardiovascular procedures.
Is the Steerable Catheter Control System reusable or single-use?
The device data does not specify whether the Steerable Catheter Control System is reusable or single-use. Clinicians should refer to the specific product instructions for use provided by Stereotaxis, Inc. for proper handling and disposal guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stereotaxis Products, Stereotaxis, Inc. FDA 510 (k) Cardiovascular Products, K183027 - Steerable catheter control system FDA 510 (k) APPLICATION FOR ..., K032937 - System, Catheter Control, Steerable FDA 510 (k) APPLICATION ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183027 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K183027 24 fields · synced Sep 27, 2026