Medical Device Manufacturer · US , Mount Olive , NJ

Catheter Robotics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2012
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Catheter Robotics, Inc. Cardiovascular ✕
3 devices
1-3 of 3
Not Cleared Dec 18, 2014
AMIGO REMOTE CATHETER SYSTEM
DEN140009 · PJB
Cardiovascular · 303d
Cleared Nov 20, 2012
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · DXX
Cardiovascular · 97d
Cleared Jun 12, 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · DXX
Cardiovascular · 187d
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