FDA 510(k) Applications Submitted by MEDRAD, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K130381 |
02/14/2013 |
ANGIOJET ULTRA POWER PULSE KIT |
MEDRAD, INC. |
K031483 |
05/12/2003 |
MEDRAD MANUAL SYRINGE LOADER |
MEDRAD, INC. |
K031808 |
06/12/2003 |
MEDRAD SWABBABLE VALVE TRANSFER SET |
MEDRAD, INC. |
K032771 |
09/08/2003 |
MEDRAD CONTINUUM MR INFUSION SYSTEM |
MEDRAD, INC. |
K133023 |
09/26/2013 |
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 |
MEDRAD, INC. |
K130637 |
03/11/2013 |
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM |
MEDRAD, INC. |
K122916 |
09/21/2012 |
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM |
MEDRAD, INC. |
K111182 |
04/27/2011 |
ANGIOJET SOLENT OMNI THROMBECTOMY SET |
MEDRAD, INC. |
K082458 |
08/26/2008 |
P3T ABDOMEN |
MEDRAD, INC. |
K082905 |
09/30/2008 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC |
MEDRAD, INC. |
K001663 |
05/31/2000 |
FRONT-LOAD POLYPROPYLENE SYRINGE |
MEDRAD, INC. |
K022431 |
07/25/2002 |
MEDRAD TRANSFER SET |
MEDRAD, INC. |
K023183 |
09/24/2002 |
MEDRAD STELLANT CT INJECTOR SYSTEM |
MEDRAD, INC. |
K013815 |
11/16/2001 |
MEDRAD QWIK-FIT SYRINGE |
MEDRAD, INC. |
K984418 |
12/10/1998 |
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET |
MEDRAD, INC. |
K050371 |
02/14/2005 |
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER |
MEDRAD, INC. |
K050456 |
02/23/2005 |
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM |
MEDRAD, INC. |
K991557 |
05/04/1999 |
MEDRAD VISTRON CT INJECTOR SYSTEM |
MEDRAD, INC. |
K982814 |
08/11/1998 |
MEDRAD VISTRON CT INJECTOR SYSTEM |
MEDRAD, INC. |
K993728 |
11/04/1999 |
MEDRAD ENVISION CT INJECTOR SYSTEM |
MEDRAD, INC. |
K982932 |
08/20/1998 |
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC |
MEDRAD, INC. |
K023596 |
10/28/2002 |
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL |
MEDRAD, INC. |
K982959 |
08/24/1998 |
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC |
MEDRAD, INC. |
K984159 |
11/19/1998 |
MEDRAD QUADRATURE CTL ARRAY COIL |
MEDRAD, INC. |
K982921 |
08/19/1998 |
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA |
MEDRAD, INC. |
K982916 |
08/19/1998 |
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC |
MEDRAD, INC. |
K982919 |
08/19/1998 |
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC |
MEDRAD, INC. |
K984257 |
11/30/1998 |
MEDRAD PHASED ARRAY NEUROVASCULAR COIL |
MEDRAD, INC. |
K061128 |
04/24/2006 |
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM |
MEDRAD, INC. |
K042784 |
10/06/2004 |
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM |
MEDRAD, INC. |
K073051 |
10/29/2007 |
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY |
MEDRAD, INC. |
K060401 |
02/15/2006 |
MEDRAD 3.0T ECOIL IMAGING SYSTEM |
MEDRAD, INC. |
K051349 |
05/24/2005 |
3.0T PROSTATE IMAGING SYSTEM |
MEDRAD, INC. |
K052827 |
10/05/2005 |
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS |
MEDRAD, INC. |
K053042 |
10/28/2005 |
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE |
MEDRAD, INC. |
K063342 |
11/06/2006 |
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS |
MEDRAD, INC. |
K072886 |
10/09/2007 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T |
MEDRAD, INC. |
K021988 |
06/18/2002 |
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM |
MEDRAD, INC. |
K011991 |
06/26/2001 |
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR |
MEDRAD, INC. |
K012950 |
09/04/2001 |
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
MEDRAD, INC. |
K973787 |
10/06/1997 |
MEDRAD 1.5T EXTREMITY ARRAY |
MEDRAD, INC. |
K974308 |
11/17/1997 |
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY |
MEDRAD, INC. |
K964642 |
11/19/1996 |
MEDRAD DISPOSABLE SYRINGES |
MEDRAD, INC. |
K974438 |
11/24/1997 |
MEDRAD ATD-T INTERFACE DEVICE |
MEDRAD, INC. |
K112086 |
07/21/2011 |
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE |
MEDRAD, INC. |
K113133 |
10/24/2011 |
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE |
MEDRAD, INC. |
K113363 |
11/15/2011 |
ANGIOJET SOLENT DISTA THROMBECTOMY SET |
MEDRAD, INC. |
K113428 |
11/21/2011 |
ANGIOJET ULTRA DVX THROMBECTOMY SET |
MEDRAD, INC. |
K960901 |
03/05/1996 |
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL |
MEDRAD, INC. |
K981094 |
03/26/1998 |
MEDRAD NEUROVASCULAR COIL |
MEDRAD, INC. |
K971380 |
04/14/1997 |
MEDRAD FLEX INTERFACE DEVICE |
MEDRAD, INC. |
K954952 |
10/30/1995 |
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL |
MEDRAD, INC. |
K964854 |
12/03/1996 |
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL |
MEDRAD, INC. |
K955626 |
12/11/1995 |
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL |
MEDRAD, INC. |
K980417 |
02/03/1998 |
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V |
MEDRAD, INC. |
K964782 |
11/27/1996 |
MEDRAD CONTRAST HOLDER |
MEDRAD, INC. |
K100798 |
03/22/2010 |
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C |
MEDRAD, INC. |
K080297 |
02/04/2008 |
MEDRAD INTEGO PET INFUSION SYSTEM |
MEDRAD, INC. |
K033247 |
10/07/2003 |
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
MEDRAD, INC. |
K063090 |
10/10/2006 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY |
MEDRAD, INC. |
K033881 |
12/15/2003 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE |
MEDRAD, INC. |
|
|