FDA 510(k) Applications Submitted by AMERICAN EDWARDS LABORATORIES

FDA 510(k) Number Submission Date Device Name Applicant
K810124 01/19/1981 SWAN-GANZ VIP THERMODILUTION CATHETER AMERICAN EDWARDS LABORATORIES
K840746 01/19/1984 URETERAL DILATOR AMERICAN EDWARDS LABORATORIES
K810162 01/22/1981 FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 AMERICAN EDWARDS LABORATORIES
K820222 01/27/1982 SWAN-GANZ VIP-CATHETER AMERICAN EDWARDS LABORATORIES
K810352 02/10/1981 SWAN-GANZ FLOW-DIRECTED THERMODILUTION AMERICAN EDWARDS LABORATORIES
K830733 03/08/1983 FORGARTY CHIN PERIPHERAL INTRAOPERATIVE AMERICAN EDWARDS LABORATORIES
K830734 03/08/1983 FORGARTY BALLOON CALIBRATOR AMERICAN EDWARDS LABORATORIES
K830892 03/21/1983 THERMODILUTION CARDIAC OUTPUT COMPUTER- AMERICAN EDWARDS LABORATORIES
K810894 04/03/1981 FOGARTY FLEXIBLE CALIBRATOR AMERICAN EDWARDS LABORATORIES
K831244 04/18/1983 URETERAL STONE EXTRACTOR CATHETER AMERICAN EDWARDS LABORATORIES
K841607 04/19/1984 AMERICAN EDWARDS LABS FLEXISCOPE AMERICAN EDWARDS LABORATORIES
K811094 04/21/1981 CARDIAC 1000 TM AMERICAN EDWARDS LABORATORIES
K811253 05/05/1981 CASSETTE READER AMERICAN EDWARDS LABORATORIES
K811254 05/05/1981 PAPER CHART RECORDER AMERICAN EDWARDS LABORATORIES
K841922 05/10/1984 ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 AMERICAN EDWARDS LABORATORIES
K811399 05/19/1981 EDSLAB CLOSED INJECTATE DELIVERY SYSTEM AMERICAN EDWARDS LABORATORIES
K811411 05/19/1981 SWAN-GANZ HEPARIN COATED, ETC. CATHETER AMERICAN EDWARDS LABORATORIES
K831659 05/23/1983 FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE AMERICAN EDWARDS LABORATORIES
K842206 06/04/1984 DIAFLEX NEPHROSTOMY BALLOON DILATOR AMERICAN EDWARDS LABORATORIES
K842323 06/13/1984 AMER. EDWARDS LAB FLEXISCOPE OBTURATOR AMERICAN EDWARDS LABORATORIES
K831949 06/16/1983 PROSTHETIC RINGS #4400 MITRAL & 4500 AMERICAN EDWARDS LABORATORIES
K811792 06/24/1981 ARRYTHMIA PRINTER OPTION AMERICAN EDWARDS LABORATORIES
K842632 07/06/1984 DILATOR/SHEATH SET AMERICAN EDWARDS LABORATORIES
K842639 07/09/1984 AMER. EDWARDS LAB DIAFLEX URETERAL DILA AMERICAN EDWARDS LABORATORIES
K832323 07/15/1983 EDSLAB PRESSURE GAUGE AMERICAN EDWARDS LABORATORIES
K842798 07/17/1984 INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH AMERICAN EDWARDS LABORATORIES
K842799 07/17/1984 PERCUTANEOUS ANGIOSCOPE DELIVERY CATH AMERICAN EDWARDS LABORATORIES
K812021 07/20/1981 VOLUMETRIC INFUSION PUMP AMERICAN EDWARDS LABORATORIES
K832474 07/26/1983 FOGARTY-CHIN PERIPHERAL DILATION CATH AMERICAN EDWARDS LABORATORIES
K832554 08/01/1983 FOGARTY 6MM SOFTJAW CLIP AMERICAN EDWARDS LABORATORIES
K822350 08/06/1982 SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH AMERICAN EDWARDS LABORATORIES
K832698 08/10/1983 ANGIOSCOPY CATHETER AMERICAN EDWARDS LABORATORIES
K822687 09/03/1982 REUSABLE FOGARTY FLEXIBLE CALIBRATOR AMERICAN EDWARDS LABORATORIES
K822723 09/07/1982 SWAN-GANZ BIPOLAR PACING CATHETER AMERICAN EDWARDS LABORATORIES
K812563 09/08/1981 SWAN-GANZ & EDSLAB HEPARIN COATED CATH. AMERICAN EDWARDS LABORATORIES
K833690 10/18/1983 COAXIAL BALLOON URETHRAL DILATOR AMERICAN EDWARDS LABORATORIES
K812935 10/20/1981 FOGARTY FLEXIBLE PROBE AMERICAN EDWARDS LABORATORIES
K833763 10/26/1983 PERICARDIAL PATCH AMERICAN EDWARDS LABORATORIES
K802670 10/27/1980 CONTIUOUS WAVE DOPPLER ULTRASOUND AMERICAN EDWARDS LABORATORIES
K823243 11/01/1982 SIDEARM Y-ADAPTOR AMERICAN EDWARDS LABORATORIES
K833997 11/21/1983 CO-SET AMERICAN EDWARDS LABORATORIES
K803057 12/02/1980 FOGARTY BALLON ANGIOPLASTY CATHETERS AMERICAN EDWARDS LABORATORIES
K803058 12/02/1980 SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. AMERICAN EDWARDS LABORATORIES
K834220 12/05/1983 HYBRID PERIPHERAL DILATION CATHETER AMERICAN EDWARDS LABORATORIES
K813514 12/15/1981 EDSLAB CATHETER COVER AMERICAN EDWARDS LABORATORIES
K834429 12/15/1983 PERIPHERAL DILATATION ANGIOPLASTY-CATH AMERICAN EDWARDS LABORATORIES
K813521 12/16/1981 TRANSLUMINAL BIPOLAR PACING PROBE AMERICAN EDWARDS LABORATORIES
K803222 12/19/1980 ADVANCEMED CCU DOCUMENTOR AMERICAN EDWARDS LABORATORIES
K803223 12/19/1980 ADVANCMED ELIMINATOR AMERICAN EDWARDS LABORATORIES
K803224 12/19/1980 ADVANCEMED HOLTER RECORDERS AMERICAN EDWARDS LABORATORIES
K803225 12/19/1980 ADVANCEMED EXAMINER AMERICAN EDWARDS LABORATORIES
K834459 12/19/1983 DIAGNOSTIC RADIOLOGY CATHETERS AMERICAN EDWARDS LABORATORIES
K834547 12/27/1983 ANGIOSCOPY CATHETER AMERICAN EDWARDS LABORATORIES
K803270 12/29/1980 GANZ CORONARY REPERFUSION CATHETER AMERICAN EDWARDS LABORATORIES
K841401 04/03/1984 SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER AMERICAN EDWARDS LABORATORIES
K862547 07/03/1986 MECHANICAL INFLATION DEVICE AMERICAN EDWARDS LABORATORIES
K862872 07/30/1986 FLEXIBLE VISUALIZATION CATHETER AMERICAN EDWARDS LABORATORIES
K873485 08/31/1987 EDSLAB (R) OCCLUSION BALLOON CATHETER AMERICAN EDWARDS LABORATORIES
K863596 09/15/1986 CHIN-FOGARTY INFLATION DEVICE AMERICAN EDWARDS LABORATORIES
K872596 07/02/1987 TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 AMERICAN EDWARDS LABORATORIES
K841374 04/03/1984 HOME PRO VOLUMETRIC INFUSION PUMP AMERICAN EDWARDS LABORATORIES
K843274 08/20/1984 MODULAR VOLUMETRIC INFUSION PUMP SYS AMERICAN EDWARDS LABORATORIES
K855000 12/13/1985 RATEMINDER III INFUSION DEVICE AMERICAN EDWARDS LABORATORIES
K863597 09/15/1986 AMERICAN EDWARDS 4.0 MM ARTHROSCOPE AMERICAN EDWARDS LABORATORIES
K863598 09/15/1986 VIDEO CAMERA SYSTEM AMERICAN EDWARDS LABORATORIES
K863604 09/16/1986 DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE AMERICAN EDWARDS LABORATORIES
K863605 09/16/1986 ARTHROSCOPIC IRRIGATION PUMP AMERICAN EDWARDS LABORATORIES
K863696 09/22/1986 ARTHROSCOPIC SURGICAL POWER DEVICE AMERICAN EDWARDS LABORATORIES
K853337 08/09/1985 TROCAR/CANNULA/SHEATH SET AMERICAN EDWARDS LABORATORIES
K853514 08/22/1985 RIGID ENDOSCOPE AMERICAN EDWARDS LABORATORIES
K842105 05/25/1984 RIGHT VENTRICULAR EJECTION FRACTION- AMERICAN EDWARDS LABORATORIES
K872529 06/26/1987 THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 AMERICAN EDWARDS LABORATORIES
K862724 07/17/1986 VEIN VALVE CUTTER AMERICAN EDWARDS LABORATORIES
K864330 11/04/1986 SHEAR FORCE GAUGE AMERICAN EDWARDS LABORATORIES
K870444 02/03/1987 HOMEPRO II VOLUMETRIC INFUSION PUMP AMERICAN EDWARDS LABORATORIES
K864997 12/22/1986 MEDTRAC VP VOLUMETRIC INFUSION PUMP AMERICAN EDWARDS LABORATORIES
K850790 02/26/1985 DIAFLEX OCCLUSION BALLOON CATHETER AMERICAN EDWARDS LABORATORIES
K850954 03/08/1985 URETERAL DILATOR & URETERAL STONE DISLODGER AMERICAN EDWARDS LABORATORIES
K851374 04/08/1985 AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE AMERICAN EDWARDS LABORATORIES
K852324 05/30/1985 URETERAL DILATOR AMERICAN EDWARDS LABORATORIES
K842410 06/19/1984 AMER. EDWARDS LAB FLEXISCOPE AMERICAN EDWARDS LABORATORIES
K842481 06/25/1984 AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE AMERICAN EDWARDS LABORATORIES
K852759 06/28/1985 AMERICAN EDWARDS LABORATORIES FLEXISCOPE AMERICAN EDWARDS LABORATORIES
K844090 10/22/1984 PERCUTANEOUS NEPHROSTOMY TROCAR SYS AMERICAN EDWARDS LABORATORIES
K845047 12/31/1984 NEPHROSTOMY GUIDEWIRE SHEATH AMERICAN EDWARDS LABORATORIES
K845048 12/31/1984 NEPHROSTOMY DRAINAGE CATHETER & STIFFENER AMERICAN EDWARDS LABORATORIES
K863986 10/14/1986 XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES AMERICAN EDWARDS LABORATORIES
K864155 10/23/1986 MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS AMERICAN EDWARDS LABORATORIES
K852793 07/01/1985 URETERAL DILATOR/SHEATH SET AMERICAN EDWARDS LABORATORIES


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