FDA 510(k) Applications Submitted by AMANDA BABCOCK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110189 |
01/24/2011 |
REPROCESSED ELECTROSURGICAL INSTRUMENT |
ASCENT HEALTHCARE SOLUTIONS |
| K100254 |
01/28/2010 |
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER |
ASCENT HEALTHCARE SOLUTIONS |
| K190127 |
01/28/2019 |
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K180710 |
03/19/2018 |
Reprocessed DecaNav Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K190785 |
03/27/2019 |
Reprocessed PentaRay Nav eco High-Density Mapping Catheter |
Innovative Health, LLC. |
| K190980 |
04/15/2019 |
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter |
Innovative Health, LLC. |
| K181126 |
04/30/2018 |
Reprocessed Visions PV .035 Digital IVUS Catheter |
Innovative Health, LLC |
| K191170 |
05/01/2019 |
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter |
Innovative Health, LLC. |
| K181458 |
06/04/2018 |
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter |
Innovative Health, LLC. |
| K181618 |
06/19/2018 |
Reprocessed Torqr Diagnostic EP Catheter |
Innovative Health, LLC. |
| K061759 |
06/22/2006 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ASCENT HEALTHCARE SOLUTIONS |
| K191880 |
07/15/2019 |
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K082023 |
07/16/2008 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ASCENT HEALTHCARE SOLUTIONS |
| K181897 |
07/16/2018 |
Reprocessed Marinr Diagnostic EP Catheter |
Innovative Health, LLC. |
| K112232 |
08/04/2011 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
STRYKER SUSTAINABILITY SOLUTIONS |
| K092425 |
08/07/2009 |
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 |
ASCENT HEALTHCARE SOLUTIONS |
| K132629 |
08/22/2013 |
REPROCESSED DILATING TIP TROCARS |
STRYKER SUSTAINABILITY SOLUTIONS |
| K182386 |
09/04/2018 |
Reprocessed Supreme Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K182488 |
09/11/2018 |
Reprocessed Response Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K123334 |
10/26/2012 |
REPROCESSED STEERABLE INTRODUCER |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| K192998 |
10/28/2019 |
Reprocessed BRK Transseptal Needle |
Innovative Health, LLC. |
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