FDA 510(k) Applications Submitted by NAOMI GONG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090001 |
01/02/2009 |
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 |
MICROVENTION, INC. |
| K150366 |
02/12/2015 |
SOFIA 6F Catheter |
MICROVENTION, INC. |
| K110741 |
03/16/2011 |
SCEPTER C OCCLUSION BALLOON CATHETER |
MICROVENTION, INC. |
| K110813 |
03/24/2011 |
HEADWAY 27 MICROCATHETER |
MICRO VENTION, INC. |
| K120917 |
03/27/2012 |
HEADWAY DUO MICROCATHETER |
MICROVENTION, INC. |
| K090891 |
03/30/2009 |
MICROPLEX COIL SYSTEM-COSMOS |
MICROVENTION, INC. |
| K150870 |
04/01/2015 |
HydroPearl Microspheres, HydroPearl Microspheres |
MICROVENTION, INC. |
| K150958 |
04/09/2015 |
LifePearl Microshperes |
MicroVention, Inc. |
| K131482 |
05/23/2013 |
SOFIA DISTAL ACCESS CATHETER |
MICRO VENTION, INC. |
| K101542 |
06/03/2010 |
HEADWAY 17 ADVANCED MICROCATHETER |
MICROVENTION, INC. |
| K091641 |
06/04/2009 |
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) |
MICROVENTION, INC. |
| K201637 |
06/16/2020 |
Aurora Evacuator +Coag |
Rebound Therapeutics |
| K121785 |
06/18/2012 |
SCEPTER C OCCLUSION BALLOON CATHETER |
MICRO VENTION, INC. |
| K091882 |
06/24/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM |
MICROVENTION, INC. |
| K201840 |
07/02/2020 |
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) |
Rebound Therapeutics |
| K191861 |
07/11/2019 |
Aurora Surgiscope System |
Rebound Therapeutics |
| K142014 |
07/24/2014 |
SOFIA DISTAL ACCESS CATHETER |
MICROVENTION, INC. |
| K093002 |
09/28/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 |
MICROVENTION, INC. |
| K173200 |
10/02/2017 |
SOFIA Plus Aspiration Catheter |
MicroVention, Inc. |
| K093160 |
10/06/2009 |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
MICROVENTION, INC. |
| K093397 |
10/30/2009 |
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
| K093647 |
11/25/2009 |
TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
| K133725 |
12/06/2013 |
TRAXCESS 14 GUIDEWIRE |
MICROVENTION, INC. |
| K113698 |
12/16/2011 |
SCEPTER XC OCCLUSION BALLOON CATHETER |
MICRO VENTION, INC. |
| K203745 |
12/22/2020 |
AURORA Evacuator +Coag |
Rebound Therapeutics |
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