Panels › Cardiovascular › Product code OBJ · Class 2
Catheter, Ultrasound, Intravascular
Regulation 870.1200
4510(k)s in 12 months (80 all time)
1recalls in 12 months (23 all time)
23recalls that name a 510(k)
Top companies in OBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Volcano Corporation | 14 | 10 |
| Boston Scientific | 12 | 2 |
| Siemens Medical Solutions USA, Inc. | 12 | 1 |
| Biosense Webster | 9 | 1 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Vasonova, Inc. | 5 | 1 |
| Acist Medical Systems, Inc. | 3 | 1 |
| Conavi Medical, Inc. | 2 | 1 |
| Philips Image Guided Therapy Corporation | 3 | 0 |
| ABBOTT MEDICAL | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2013 | K122878 | HD-IVUS ULTRASOUND IMAGING SYSTEM Silicon Vally Medical Instruments, Inc. | OBJ |
| Sep 10, 2012 | K121273 | VISIONS PV .035 DITITAL IVUS CATHETER Volcano Corporation | OBJ |
| Jun 14, 2012 | K113008 | KODAMA INTRAVASCULAR ULRASOUND CATHETER Silicon Vally Medical Instruments, Inc. | OBJ |
| Apr 5, 2012 | K120697 | EAGLE EYE PLATINUM ST CATHETER Volcano Corporation | OBJ |
| Nov 18, 2011 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER Biosense Webster, Inc. | OBJ |
| Aug 4, 2011 | K111043 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER Boston Scientific Corp | OBJ |
| Feb 18, 2011 | K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE Vasonova, Inc. | OBJ |
| Feb 18, 2011 | K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET Vasonova, Inc. | OBJ |
| Jun 22, 2010 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 Biosense Webster, Inc. | OBJ |
| Dec 10, 2009 | K092596 | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER Volcano Corporation | OBJ |
| Dec 4, 2009 | K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 Biosense Webster, Inc. | OBJ |
| Aug 7, 2009 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 Biosense Webster, Inc. | OBJ |
| Oct 15, 2008 | K081626 | FLOWPICC CONSOLE Vasonova, Inc. | OBJ |
| Sep 26, 2008 | K081808 | ACUNAV V ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. | OBJ |
| Sep 26, 2008 | K081625 | FLOWPICC STYLET Vasonova, Inc. | OBJ |
| May 12, 2008 | K080891 | REVOLUTION 45MHZ IVUS IMAGING CATHETER Volcano Corporation | OBJ |
| Jan 14, 2008 | K073473 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 Volcano Corporation | OBJ |
| Jan 4, 2008 | K071554 | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM Volcano Corporation | OBJ |
| Aug 31, 2007 | K071660 | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 Volcano Corporation | OBJ |
| Jun 29, 2007 | K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F Siemens Medical Solutions USA, Inc. | OBJ |
| May 15, 2007 | K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 Biosense Webster, Inc. | OBJ |
| Aug 18, 2005 | K051337 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 Volcano Corporation | OBJ |
| Jul 14, 2005 | K051679 | ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp | OBJ |
| Jun 20, 2005 | K050995 | REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER Volcano Corporation | OBJ |
| Oct 15, 2004 | K042593 | ACUSON ACUNAV 8F ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. | OBJ |
| Jul 23, 2004 | K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific Scimed, Inc. | OBJ |
| Jun 2, 2004 | K041134 | COMBOMAP PRESSURE AND FLOW SYSTEM Volcano Therapeutics, Inc. | OBJ |
| Feb 24, 2004 | K033650 | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. | OBJ |
| Jun 23, 2003 | K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 Jomed, Inc. | OBJ |
| Mar 3, 2003 | K030524 | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN Cd Leycom BV, NL | OBJ |
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