FDA 510(k) Applications Submitted by ERIC ELLIOTT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160173 |
01/27/2016 |
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) |
Boston Scientific Corporation |
| K160514 |
02/24/2016 |
OptiCross 18, 30 MHz Peripheral Imaging Catheter |
BOSTON SCIENTIFIC CORPORATION |
| K161125 |
04/21/2016 |
OptiCross X, 40 MHz Coronary Imaging Catheter |
Boston Scientific Corporation |
| K171268 |
05/01/2017 |
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter |
MicroTherapeutics, Inc. d/b/a ev3 Neurovascular |
| K111485 |
05/31/2011 |
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX |
Boston Scientific Corporation |
| K111498 |
05/31/2011 |
FATHOM (TM) 14 STEERABLE GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
| K192460 |
09/09/2019 |
Sentinel Cerebral Protection System |
Boston Scientific Corporation |
| K123621 |
11/23/2012 |
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
| K153617 |
12/18/2015 |
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) |
BOSTON SCIENTIFIC CORPORATION |
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