Sensei Catheter Control System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073225 FDA 510(k)
- FDA Product Code
- DXX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1290 FDA 510(k)
- Regulation Number
- 870.1290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The Sensei Catheter Control System is a steerable, catheter control system designed for accurate positioning, manipulation, and stable control of catheter and catheter-based technologies during cardiovascular procedures. It is a robotic flexible platform that combines 3D catheter control and 3D visualisation. The system is controlled by a physician and is used for cardiovascular procedures.
The Sensei Catheter Control System is supplied with various registration numbers, including 2246552, 3003084417, 2953359, 3017403339, 3008627763, and 2011171. It has a product code of DXX and is classified as a class 2 device. The system has received FDA 510K clearance and is manufactured by Hansen Medical, Inc.
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: Sensei robotic catheter system - Wikipedia, Hansen Medical unveils next generation robotic catheter system and two ..., Hansen Medical | Sensei X Robotic Catheter System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073225 | Class II | Active |
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Manufacturer
- Manufacturer
- Hansen Medical, Inc.
Sources (1)
- FDA 510(k) K073225 24 fields · synced Sep 22, 2026