Panels › Cardiovascular › Product code DXX · Class 2
System, Catheter Control, Steerable
Regulation 870.1290
2510(k)s in 12 months (34 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in DXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hansen Medical | 10 | 4 |
| Corindus, Inc. | 9 | 0 |
| Stereotaxis, Inc. | 9 | 0 |
| Catheter Research C/O Burditt, Bowles & Radzius | 2 | 0 |
| Catheter Robotics, Inc. | 2 | 0 |
| Hanson Medical, Inc. | 1 | 0 |
| Microbot Medical , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2016 | Hansen Medical Inc Magellan Robotic Catheter Accessory Kits,
Model number MACC 50 and MACC80.
Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a M Terminated |
DXX | K111004 K132369 +2 |
| Apr 15, 2015 | Hansen Medical Inc Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. Terminated |
DXX | K111004 K132369 +1 |
| Dec 30, 2014 | Hansen Medical Inc Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.
Product Usage:
The Sensei X Robotic Cat Terminated |
DXX | K052480 K073225 +3 |
| Apr 6, 2010 | Hansen Medical Inc Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain Terminated |
DXX | K090365 |
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