FDA 510(k) Applications Submitted by LISA TO

FDA 510(k) Number Submission Date Device Name Applicant
K152232 08/07/2015 Quest Diagnostics HairCheck-DT (Cocaine) Quest Diagnostics Incorporated
K090141 01/21/2009 PRONTOSAN ANTIMICROBIAL WOUND GEL B. BRAUN MEDICAL, INC.
K100241 01/27/2010 CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 B. BRAUN MEDICAL, INC.
K090995 04/07/2009 B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET B. BRAUN MEDICAL, INC.
K102033 07/19/2010 COMBITRANS MONITORING SETS AND ACCESSORIES B. BRAUN MELSUNGEN AG
K112515 08/30/2011 PENCAN SPINAL NEEDLE B. BRAUN MEDICAL, INC.
K113059 10/14/2011 CONTIPLEX FX B. BRAUN MEDICAL, INC.
K153297 11/13/2015 Perifix and Contiplex Catheter B. BRAUN MEDICAL INC
K133632 11/26/2013 PERICAN ULTRA B.BRAUN MEDICAL, INC
K014172 12/20/2001 NELSON ELECTROSURGICAL UNIT, MODEL GN640 AESCULAP, INC.
K014207 12/21/2001 REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 AESCULAP, INC.
K970269 01/23/1997 CLINICATH IR PERIPHERALLY INSERTED CATHETER SIMS DELTEC, INC.
K020655 03/01/2002 DELTEC INSULIN INFUSION PUMP AND ACCESSORIES DELTEC, INC.
K000842 03/15/2000 CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM SIMS DELTEC, INC.
K000942 03/23/2000 CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 SIMS DELTEC, INC.
K030983 03/28/2003 TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY DELTEC, INC.
K961580 04/24/1996 PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS SIMS DELTEC, INC.
K091206 04/24/2009 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL TRANSOMA MEDICAL
K031361 04/30/2003 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP DELTEC, INC.
K111658 06/14/2011 AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC INC.
K111657 06/14/2011 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE MEDTRONIC, INC.
K021999 06/19/2002 GRIPPER PLUS NEEDLE DELTEC, INC.
K131964 06/27/2013 BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE MEDTRONIC INC.
K022221 07/09/2002 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS DELTEC, INC.
K132712 08/29/2013 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC.
K172626 09/01/2017 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot Medtronic, Inc.
K142784 09/26/2014 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Medtronic, Inc
K172984 09/27/2017 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Medtronic, Inc.
K973862 10/09/1997 PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS SIMS DELTEC, INC.
K073147 11/08/2007 SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 TRANSOMA MEDICAL
K984055 11/13/1998 CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS SIMS DELTEC, INC.
K974471 11/26/1997 PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A SIMS DELTEC, INC.
K955407 11/27/1995 PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS SIMS DELTEC, INC.
K974661 12/15/1997 0.2 U BACTERIAL FILTER SIMS DELTEC, INC.
K994216 12/15/1999 PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC.
K083828 12/23/2008 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT TRANSOMA
K023297 10/02/2002 URS-1B (BLOOD TEST) TECO DIAGNOSTICS
K010426 02/13/2001 PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER SIMS DELTEC, INC.
K962695 07/11/1996 PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER SIMS DELTEC, INC.
K992697 08/11/1999 PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM SIMS DELTEC, INC.
K992880 08/27/1999 P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC.
K011102 04/11/2001 ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM AESCULAP, INC.
K011556 05/21/2001 MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM AESCULAP, INC.
K012219 07/16/2001 SCALPFIX CLIP SYSTEM AESCULAP, INC.
K012986 09/06/2001 BIPOLAR IRRIGATION FORCEPS AESCULAP, INC.
K003608 11/22/2000 SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY AESCULAP, INC.
K003965 12/22/2000 MRI SAFE INSTRUMENTS AESCULAP, INC.


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