FDA 510(k) Applications Submitted by BAXTER HEALTHCARE CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K981089 03/25/1998 TISSOMAT AND SPRAY SET BAXTER HEALTHCARE CORP.
K963933 10/01/1996 PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER BAXTER HEALTHCARE CORP.
K020666 03/01/2002 DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML BAXTER HEALTHCARE CORP.
K003193 10/12/2000 DUPLOGRIP BAXTER HEALTHCARE CORP.
K003747 12/04/2000 C1-INHIBITOR MICROTITER ASSAY DEVICE BAXTER HEALTHCARE CORP.
K014088 12/12/2001 DUPLOREACH BAXTER HEALTHCARE CORP.
K081721 06/18/2008 TRICOS A RESORBABLE SUBSTITUTE BAXTER HEALTHCARE CORP.
K051722 06/27/2005 TRICOS T BAXTER HEALTHCARE CORP.
K961825 05/10/1996 ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 BAXTER HEALTHCARE CORP.
K972579 07/10/1997 HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE BAXTER HEALTHCARE CORP.
K990953 03/22/1999 RENAL LINK BAXTER HEALTHCARE CORP.
K030974 03/28/2003 EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 BAXTER HEALTHCARE CORP.
K030975 03/28/2003 EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 BAXTER HEALTHCARE CORP.
K021615 05/16/2002 BAXTER ACCURA SYSTEM, MODEL 5M5660 BAXTER HEALTHCARE CORP.
K041428 05/28/2004 ACCUSOL DIALYSIS SOLUTION BAXTER HEALTHCARE CORP.
K031676 05/30/2003 HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q BAXTER HEALTHCARE CORP.
K061515 06/01/2006 RENALSOFT BAXTER HEALTHCARE CORP.
K012988 09/06/2001 HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 BAXTER HEALTHCARE CORP.
K102936 10/04/2010 HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R BAXTER HEALTHCARE CORP.
K023664 10/31/2002 SYNTRA + DIALYZER, MODEL 200 BAXTER HEALTHCARE CORP.
K974652 12/12/1997 BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER BAXTER HEALTHCARE CORP.
K053512 12/16/2005 HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 BAXTER HEALTHCARE CORP.
K090002 01/02/2009 ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A BAXTER HEALTHCARE CORP.
K962161 06/04/1996 BAXTER NEBULIZER CAP MODEL 2D0868 BAXTER HEALTHCARE CORP.
K132734 09/03/2013 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS BAXTER HEALTHCARE CORP.
K123868 12/17/2012 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP.
K130531 03/01/2013 ULTRAFUSE BAXTER HEALTHCARE CORP.
K960955 03/11/1996 JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING BAXTER HEALTHCARE CORP.
K955816 12/26/1995 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR BAXTER HEALTHCARE CORP.
K001063 04/03/2000 SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 BAXTER HEALTHCARE CORP.
K992532 07/29/1999 VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING BAXTER HEALTHCARE CORP.
K070125 01/16/2007 COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION BAXTER HEALTHCARE CORP.
K010566 02/26/2001 COLLEAGUE VOLUMETRIC INFUSION PUMP BAXTER HEALTHCARE CORP.
K040985 04/15/2004 PUMP CONNECTIVITY INTERFACE BAXTER HEALTHCARE CORP.
K041191 05/06/2004 COLLEAGUE VOLUMETRIC INFUSION PUMPS BAXTER HEALTHCARE CORP.
K031566 05/19/2003 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 BAXTER HEALTHCARE CORP.
K002211 07/21/2000 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 BAXTER HEALTHCARE CORP.
K002679 08/28/2000 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 BAXTER HEALTHCARE CORP.
K003616 11/22/2000 COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP BAXTER HEALTHCARE CORP.
K953741 08/10/1995 THERMACYL BLOOD/FLUID WARMER BAXTER HEALTHCARE CORP.
K052973 10/24/2005 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K BAXTER HEALTHCARE CORP.
K993120 09/20/1999 MODIFIED BLOOD RECIPIENT SET BAXTER HEALTHCARE CORP.
K003730 12/04/2000 CHEMO-AIDE DISPENSING PIN BAXTER HEALTHCARE CORP.
K984381 12/08/1998 BURETROL SOLUTION SETS BAXTER HEALTHCARE CORP.
K982672 07/31/1998 COLLEAGUE PUMP SYRINGE ADAPTER SET BAXTER HEALTHCARE CORP.
K983294 09/21/1998 ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 BAXTER HEALTHCARE CORP.
K003245 10/17/2000 HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML BAXTER HEALTHCARE CORP.
K031882 06/18/2003 ENDOSCOPIC APPLICATOR BAXTER HEALTHCARE CORP.
K961008 03/12/1996 AUTOMIX 3+3/AS COMPOUNDER SYSTEM BAXTER HEALTHCARE CORP.
K974397 11/21/1997 STERILE SALINE FOR CATHETER CARE BAXTER HEALTHCARE CORP.
K955622 12/11/1995 AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; BAXTER HEALTHCARE CORP.
K984590 12/28/1998 0.9% SODIUM CHLORIDE FLUSH SYRINGE BAXTER HEALTHCARE CORP.
K020485 02/13/2002 ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML BAXTER HEALTHCARE CORP.
K970438 02/05/1997 INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS BAXTER HEALTHCARE CORP.
K972159 06/09/1997 FENWAL 40 MICRON TRANSFUSION FILTER BAXTER HEALTHCARE CORP.
K964853 12/03/1996 INTRAVIA CONTAINER, EMPTY BAXTER HEALTHCARE CORP.
K964850 12/03/1996 SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER BAXTER HEALTHCARE CORP.
K962893 07/25/1996 INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE BAXTER HEALTHCARE CORP.
K000657 02/28/2000 LUER ACCESS UNIVERSAL VIAL ADAPTER BAXTER HEALTHCARE CORP.
K961225 03/29/1996 CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET BAXTER HEALTHCARE CORP.
K981318 04/10/1998 DUAL LUER LOCK CAP BAXTER HEALTHCARE CORP.
K961495 04/18/1996 HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE BAXTER HEALTHCARE CORP.
K971701 05/08/1997 CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP.
K981792 05/21/1998 SOLUTION ADMINISTRATION SET BAXTER HEALTHCARE CORP.
K962581 07/01/1996 STOPCOCK MANIFOLD GANGS BAXTER HEALTHCARE CORP.
K982822 08/11/1998 FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 BAXTER HEALTHCARE CORP.
K003225 10/16/2000 SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE BAXTER HEALTHCARE CORP.
K984060 11/13/1998 LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP.
K974571 12/08/1997 SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE BAXTER HEALTHCARE CORP.
K960787 02/26/1996 TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS BAXTER HEALTHCARE CORP.
K961154 03/22/1996 BAXTER SODIUM ACETATE INFANT HEEL WARMER BAXTER HEALTHCARE CORP.
K962022 05/23/1996 POWERCUT GOLD SURGICAL SYSTEM BAXTER HEALTHCARE CORP.
K964029 10/07/1996 EMERGENCY RELIEF KIT SYSTEM BAXTER HEALTHCARE CORP.
K060074 01/10/2006 INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 BAXTER HEALTHCARE CORP.
K130245 01/31/2013 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO BAXTER HEALTHCARE CORP.
K071222 05/02/2007 INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORP.
K111217 05/02/2011 ADDITIVE CAP BAXTER HEALTHCARE CORP.
K081289 05/07/2008 V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE BAXTER HEALTHCARE CORP.
K051253 05/16/2005 MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) BAXTER HEALTHCARE CORP.
K101385 05/18/2010 DUAL LUER LOCK CAP, MODEL 2C6250 BAXTER HEALTHCARE CORP.
K051370 05/26/2005 STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 BAXTER HEALTHCARE CORP.
K072576 09/13/2007 CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED BAXTER HEALTHCARE CORP.
K042936 10/25/2004 SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP.
K113227 11/01/2011 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER BAXTER HEALTHCARE CORP.
K103551 12/02/2010 INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, BAXTER HEALTHCARE CORP.
K123874 12/17/2012 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S BAXTER HEALTHCARE CORP.
K121092 04/10/2012 FLOWEASE [SUBCUTANEOUS] INFUSION SET BAXTER HEALTHCARE CORP.
K971168 03/31/1997 ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE BAXTER HEALTHCARE CORP.
K000664 02/28/2000 VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS BAXTER HEALTHCARE CORP.
K030099 01/10/2003 BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 BAXTER HEALTHCARE CORP.
K970591 02/18/1997 BLOOD MONITOR PUMP BAXTER HEALTHCARE CORP.
K980658 02/19/1998 PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 BAXTER HEALTHCARE CORP.
K970654 02/21/1997 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) BAXTER HEALTHCARE CORP.
K970661 02/21/1997 CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) BAXTER HEALTHCARE CORP.
K970662 02/21/1997 CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) BAXTER HEALTHCARE CORP.
K970663 02/21/1997 CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) BAXTER HEALTHCARE CORP.
K970653 02/21/1997 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) BAXTER HEALTHCARE CORP.
K001422 05/05/2000 PSN HEMODIALYZER, MODELS PSN 170, PSN 210 BAXTER HEALTHCARE CORP.
K001685 06/01/2000 PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 BAXTER HEALTHCARE CORP.
K002210 07/21/2000 SYNTRA DIALYZER, MODEL SYNTRA 120, 160 BAXTER HEALTHCARE CORP.
K992894 08/27/1999 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORP.
K013562 10/26/2001 AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE BAXTER HEALTHCARE CORP.
K955277 11/17/1995 ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS BAXTER HEALTHCARE CORP.
K980656 02/19/1998 PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 BAXTER HEALTHCARE CORP.
K042410 09/07/2004 BAXJECT II BAXTER HEALTHCARE CORP.
K103245 11/02/2010 CELSTAT BAXTER HEALTHCARE CORP.
K952879 06/23/1995 SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT BAXTER HEALTHCARE CORP.
K963203 08/15/1996 BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT BAXTER HEALTHCARE CORP.
K960509 02/05/1996 18 GAUGE TRU-CUT BIOPSY NEEDLE BAXTER HEALTHCARE CORP.
K961341 04/08/1996 CONVERTORS POLYOLEFIN FABRIC GOWNS BAXTER HEALTHCARE CORP.
K962907 07/25/1996 SKINNY,FRANSEEN,WESCOTT NEEDLES BAXTER HEALTHCARE CORP.
K963390 08/28/1996 BIOPSY INTRODUCER NEEDLE BAXTER HEALTHCARE CORP.
K973654 09/25/1997 VIAL-MATE RECONSTITUTION DEVICE (2B8071) BAXTER HEALTHCARE CORP.
K961703 05/02/1996 COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) BAXTER HEALTHCARE CORP.
K974155 11/04/1997 BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT BAXTER HEALTHCARE CORP.
K081717 06/18/2008 TRICOS A RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORP.
K002739 09/01/2000 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K BAXTER HEALTHCARE CORP.
K011317 04/30/2001 MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP.
K982102 06/15/1998 SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY BAXTER HEALTHCARE CORP.
K002380 08/04/2000 INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP.
K993387 10/08/1999 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K BAXTER HEALTHCARE CORP.
K021274 04/22/2002 PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 BAXTER HEALTHCARE CORP.


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