FDA 510(k) Applications Submitted by SMITHS MEDICAL MD, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K072657 09/20/2007 POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS SMITHS MEDICAL MD, INC.
K072059 07/26/2007 GRIPPER MICRO NEEDLE SMITHS MEDICAL MD, INC.
K080743 03/17/2008 LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP SMITHS MEDICAL MD, INC.
K081156 04/23/2008 CADD MEDICATION CASSETTE RESERVOIR SMITHS MEDICAL MD, INC.
K062323 08/09/2006 DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 SMITHS MEDICAL MD, INC.
K042172 08/11/2004 CLEO 90 INFUSION SET SMITHS MEDICAL MD, INC.
K072955 10/19/2007 CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) SMITHS MEDICAL MD, INC.
K091181 04/23/2009 LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS SMITHS MEDICAL MD, INC.
K111386 05/18/2011 MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) SMITHS MEDICAL MD, INC.
K060036 01/05/2006 PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER SMITHS MEDICAL MD, INC.
K051568 06/14/2005 CADD-MS 3 AMBULATORY INFUSION PUMP SMITHS MEDICAL MD, INC.
K062592 09/01/2006 CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE SMITHS MEDICAL MD, INC.
K040636 03/10/2004 CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET SMITHS MEDICAL MD, INC.
K033686 11/24/2003 PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM SMITHS MEDICAL MD, INC.
K070116 01/12/2007 POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE SMITHS MEDICAL MD, INC.
K072144 08/02/2007 CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR SMITHS MEDICAL MD, INC.
K082783 09/23/2008 CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE SMITHS MEDICAL MD, INC.
K031738 06/04/2003 SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER SMITHS MEDICAL MD, INC.
K101180 04/27/2010 GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, SMITHS MEDICAL MD, INC.
K112407 08/22/2011 SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS SMITHS MEDICAL MD, INC.


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