FDA 510(k) Applications Submitted by E F WADDELL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K151536 |
06/08/2015 |
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm |
MRI INTERVENTIONS, INC. |
| K142505 |
09/05/2014 |
ClearPoint System |
MRI INTERVENTIONS, INC. |
| K132436 |
08/05/2013 |
VARIOGUIDE DRILL KIT |
MRI INTERVENTIONS, INC. |
| K111802 |
06/27/2011 |
SV BRAIN ARRAY, SIEMENS 3T |
MRI INTERVENTIONS, INC. |
| K122456 |
08/13/2012 |
MRII CRAINIAL DRILL |
MRI INTERVENTIONS, INC. |
| K980619 |
02/18/1998 |
SABRATEK PATIENT HOME MANAGEMENT SYSTEM |
SABRATEK CORP. |
| K111073 |
04/18/2011 |
SURGIVISION INC. CLEARPOINT SYSTEM |
SURGI-VISION, INC. |
| K102101 |
07/27/2010 |
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA |
SURGIVISION, INC. |
| K081881 |
07/02/2008 |
GISH TUBING AND CONNECTORS WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K123605 |
11/21/2012 |
SMARTFLOW CATHETER |
MRI INTERVENTIONS, INC. |
|
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