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510k Database
Manufacturers
US
Hansen Medical
Medical Device Manufacturer
·
US , Mountain View , CA
Hansen Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hansen Medical
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 07, 2014
MAGELLAN ROBOTIC SYSTEM
K141614
·
DXX
Cardiovascular
·
52d
Cleared
Feb 07, 2014
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER...
K133552
·
DRA
Cardiovascular
·
80d
Cleared
Aug 29, 2012
ARTISAN EXTEND CONTROL CATHETER
K122275
·
DRA
Cardiovascular
·
30d
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3
Cardiovascular
3