Corpath 200 System
510(k) K120834
Corpath 200 System is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K120834 on 19 Jul 2012, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120834 | Date19 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K120834
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1290
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DXX (System, Catheter Control, Steerable).
- SENSEI X ROBOTIC CATHETER SYSTEM by Hansen Medical, Inc.
- HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH by Hansen Medical, Inc.
- ODYSSEY WORKSTATION by Stereotaxis, Inc.
- NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 by Stereotaxis, Inc.
- CRI STEERABLE CATHETER CONTROL SYSTEM by Catheter Research C/O Burditt, Bowles & Radzius
- AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES by Catheter Robotics, Inc.
- AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES by Catheter Robotics, Inc.
- LIBERTY Endovascular Robotic System (LIBERTYOS) by MICROBOT MEDICAL LTD
- CRI Electronic Control System by Catheter Research C/O Burditt, Bowles & Radzius