FDA 510(k) Applications Submitted by Eben Gordon
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010162 |
01/17/2001 |
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 |
MICRO THERAPEUTICS, INC. |
| K210176 |
01/22/2021 |
FlowSaver Blood Filter |
Inari Medical |
| K180329 |
02/06/2018 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
| K050347 |
02/11/2005 |
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
| K010497 |
02/21/2001 |
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 |
MICRO THERAPEUTICS, INC. |
| K180466 |
02/21/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical, Inc. |
| K080698 |
03/12/2008 |
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP |
SENORX, INC. |
| K130709 |
03/15/2013 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
| K080791 |
03/20/2008 |
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 |
SENORX, INC. |
| K021010 |
03/29/2002 |
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE |
ENDOCARE, INC. |
| K081079 |
04/16/2008 |
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY |
SENORX, INC. |
| K081085 |
04/16/2008 |
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS |
SENORX, INC. |
| K081170 |
04/24/2008 |
PROSTATE TISSUE MARKER |
SENORX, INC. |
| K071229 |
05/03/2007 |
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY |
SENORX, INC. |
| K011526 |
05/17/2001 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 |
MICRO THERAPEUTICS, INC. |
| K011535 |
05/18/2001 |
CADENCE PRECISION INJECTOR, MODEL 103-0304 |
MICRO THERAPEUTICS, INC. |
| K181325 |
05/18/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical, Inc. |
| K191368 |
05/22/2019 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K011656 |
05/29/2001 |
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 |
MICRO THERAPEUTICS, INC. |
| K201541 |
06/09/2020 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K011937 |
06/21/2001 |
TRULINE INFUSION CATHETERS |
MICRO THERAPEUTICS, INC. |
| K191710 |
06/26/2019 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K181694 |
06/27/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K122036 |
07/11/2012 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
| K152097 |
07/28/2015 |
Retraction Aspirator |
INARI MEDICAL |
| K032333 |
07/29/2003 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
| K192036 |
07/30/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
| K092323 |
08/04/2009 |
CONTURA CAVITY MAINTENANCE CATHETER |
SENORX, INC. |
| K082264 |
08/11/2008 |
CONTURA LUMEN MARKER |
SENORX, INC. |
| K182233 |
08/17/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K202345 |
08/18/2020 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
| K192332 |
08/27/2019 |
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
| K112478 |
08/29/2011 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
| K182531 |
09/14/2018 |
ClotTriever Thrombectomy System |
Inari Medical |
| K142827 |
09/30/2014 |
Visi Mobile Monitoring System, Visi Mobile Chest Sensor |
Sotera Wireless, Inc. |
| K162970 |
10/24/2016 |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator |
Inari Medical |
| K023757 |
11/08/2002 |
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 |
ENDOCARE, INC. |
| K173470 |
11/08/2017 |
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
| K093512 |
11/13/2009 |
ENCOR BREAST BIOPSY SYSTEM |
SENORX, INC. |
| K133586 |
11/21/2013 |
VISI MOBILE MONITIORING SYSTEM |
SOTERA WIRELESS, INC |
| K173672 |
11/30/2017 |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter |
Inari Medical |
| K143563 |
12/16/2014 |
Infusion Aspiration Catheter System |
Inari Medical, Inc. |
| K163549 |
12/16/2016 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
| K193462 |
12/16/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
| K143751 |
12/31/2014 |
Visi Mobile Monitoring System |
Sotera Wireless, Inc. |
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