FDA 510(k) Applications Submitted by PACESETTER SYSTEMS

FDA 510(k) Number Submission Date Device Name Applicant
K830016 01/03/1983 VASCUTEK VASCULAR PROTHESIS VP1200K/50K PACESETTER SYSTEMS
K790141 01/19/1979 PULSE GENERATOR, R WAVE DEMAND PACESETTER SYSTEMS
K810139 01/21/1981 ELECTRODE, PACEMAKER, PERMANENT PACESETTER SYSTEMS
K790218 01/30/1979 BIPOLAR LEAD ADAPTOR, MODEL BA-415 PACESETTER SYSTEMS
K810286 02/02/1981 PACEPATH IMPLANT. ENDOCARD. PACING LEAD PACESETTER SYSTEMS
K830570 02/22/1983 PERSONAL MEDICATION INFUSER PACESETTER SYSTEMS
K790428 03/01/1979 MDL-201A & T DL-201A PULSE GENERATOR PACESETTER SYSTEMS
K810551 03/02/1981 PACEMAKER LEAD ADAPTER PACESETTER SYSTEMS
K810582 03/03/1981 ELECTRODE, PACEMAKER PERMANENT PACESETTER SYSTEMS
K810850 03/30/1981 PERSONAL MEDICATION INFUSER PACESETTER SYSTEMS
K821003 04/09/1982 PROGRAMMALITH II, #225 & 226 PACESETTER SYSTEMS
K841739 04/27/1984 MODEL 866 PERMATHANE BIPOLAR, COAXIAL PACESETTER SYSTEMS
K811200 04/30/1981 PACEPATH IMPLANTABLE ENDOCARD. PACING LD PACESETTER SYSTEMS
K831435 05/04/1983 VENTRICULAR PACING LEADS MODELS 865/867 PACESETTER SYSTEMS
K831436 05/04/1983 UNIPOLAR ATRIAL J PACING LEAD MODEL 869 PACESETTER SYSTEMS
K831443 05/05/1983 PACELINE PATIENT TRANSMITTER MODEL 324 PACESETTER SYSTEMS
K831444 05/05/1983 SINGLE USE SYRINGE #103 PERSONAL MEDIC PACESETTER SYSTEMS
K831445 05/05/1983 INFUSION SETS #'S 124 & 142 PERSONAL PACESETTER SYSTEMS
K790873 05/07/1979 MODEL 221 PROGRAMALITH PULSE GENERATOR PACESETTER SYSTEMS
K841885 05/07/1984 FASTPASS IMPLANTABLE ENDOCARDIAL PAC PACESETTER SYSTEMS
K821549 05/25/1982 PACEMAKER 445 ADAPTER PACESETTER SYSTEMS
K821547 05/25/1982 PACEMAKER UNIPOLAR ADAPTER PACESETTER SYSTEMS
K821548 05/25/1982 PACEMAKER CONNECTOR PLUG PACESETTER SYSTEMS
K801416 06/16/1980 PACEPATH MODEL 810 PACESETTER SYSTEMS
K801417 06/16/1980 PACEPATH MODEL 819 PACESETTER SYSTEMS
K801455 06/24/1980 LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM PACESETTER SYSTEMS
K821947 06/30/1982 FASTPASS IMPLANTABLE ENDOCARD. PACING PACESETTER SYSTEMS
K801763 07/28/1980 VIVALITH 5, - MDL-201A & TDL-201A PACESETTER SYSTEMS
K791552 08/14/1979 MODELS UL-804 AND BL-801 UNIPOLAR LEADS PACESETTER SYSTEMS
K781424 08/17/1978 GENERATORS: UDL-201B, BDL-201B, MDL-201B PACESETTER SYSTEMS
K801978 08/19/1980 PROGRAMALITH #'S 221, 222, 221A & 222A PACESETTER SYSTEMS
K771641 08/29/1977 UNIVERSAL LEAD ADAPTER, UA-414 PACESETTER SYSTEMS
K771642 08/29/1977 ADAPTER A-413 PACESETTER SYSTEMS
K822639 09/01/1982 AFP SYSTEM PULSE GENERATOR MODEL 261/262 PACESETTER SYSTEMS
K832987 09/01/1983 PERMANTHANE #866 BIPOLAR COAXIAL PACESETTER SYSTEMS
K760757 10/01/1976 MODEL 100 CARDIAC PACEMAKER PACESETTER SYSTEMS
K802407 10/03/1980 PACEMAKER LEAD ADAPTOR MODEL 431 PACESETTER SYSTEMS
K812815 10/07/1981 MODEL 833 ENDOCARDIAL TINED LEAD PACESETTER SYSTEMS
K812816 10/07/1981 MODEL 841 ENDOCARDIAL TINED LEAD PACESETTER SYSTEMS
K781776 10/13/1978 PACING LEADS MODEL UL-811 AND UL-813 PACESETTER SYSTEMS
K823033 10/14/1982 ELECTRODE, PACEMAKER, PERMANENT PACESETTER SYSTEMS
K833647 10/17/1983 PACEMAKER SYS ANALYZER #384 PACESETTER SYSTEMS
K772050 10/31/1977 TDL-100 B PACESETTER SYSTEMS
K772051 10/31/1977 MDL-201 PACESETTER SYSTEMS
K833824 10/31/1983 ENDOCARDIAL SCREW-IN LEAD 859 & 861 PACESETTER SYSTEMS
K823242 11/01/1982 PROGRAMALITH PROGRAMMER PACESETTER SYSTEMS
K813150 11/06/1981 DIRECTIONAL BOOT PACESETTER SYSTEMS
K813151 11/06/1981 VITATRON INSERT PACESETTER SYSTEMS
K813152 11/06/1981 ELECTRODE TERMINAL CAP PACESETTER SYSTEMS
K813153 11/06/1981 TEST MAGNET PACESETTER SYSTEMS
K813154 11/06/1981 ADAPTING SLEEVE PACESETTER SYSTEMS
K761143 11/26/1976 LITHIUM IODIDE BATTERY PACEMAKER (#201) PACESETTER SYSTEMS
K823559 12/02/1982 AFP PULSE GENERATOR PACESETTER SYSTEMS
K834431 12/16/1983 PACING ELECTRODE PACESETTER SYSTEMS
K860546 02/13/1986 DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 PACESETTER SYSTEMS
K854195 10/15/1985 PROGRAMALITH III MODELS 238 & 239 PACESETTER SYSTEMS
K823878 12/27/1982 IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 PACESETTER SYSTEMS
K902147 05/15/1990 ENDOCARDIAL SCREW-IN LEAD MODEL 1028T PACESETTER SYSTEMS
K860857 03/07/1986 SOF SET, MODELS 113 AND 114 PACESETTER SYSTEMS
K861436 04/17/1986 SOF SET, MODELS 111 AND 112 PACESETTER SYSTEMS
K843703 09/21/1984 PERMATHANE 865 & 867 UNIPOLAR POLYURETH PACESETTER SYSTEMS
K844334 11/07/1984 VIVALITH II 301 PULSE GENERATOR PACESETTER SYSTEMS
K850464 02/07/1985 PROGRAMALITH III 240 PULSE GENERATOR PACESETTER SYSTEMS
K854405 11/01/1985 PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD PACESETTER SYSTEMS
K870824 01/13/1987 ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 PACESETTER SYSTEMS
K900512 02/02/1990 SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS PACESETTER SYSTEMS
K890547 02/03/1989 SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS PACESETTER SYSTEMS
K900550 02/06/1990 FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T PACESETTER SYSTEMS
K850576 02/13/1985 PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR PACESETTER SYSTEMS
K850651 02/19/1985 PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR PACESETTER SYSTEMS
K850652 02/19/1985 PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD PACESETTER SYSTEMS
K910924 03/05/1991 ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE PACESETTER SYSTEMS
K851145 03/21/1985 PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD PACESETTER SYSTEMS
K861140 03/26/1986 PROGRAMALITH III PULSE GENERATOR PACESETTER SYSTEMS
K861422 04/16/1986 PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY PACESETTER SYSTEMS
K851665 04/22/1985 PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE PACESETTER SYSTEMS
K851861 04/26/1985 PROGRAMALITH III MODEL 249 PULSE GENERATOR PACESETTER SYSTEMS
K862226 06/11/1986 DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS PACESETTER SYSTEMS
K873931 09/14/1987 MODIFIED MODELS 1025M & 1026T PACING LEAD PACESETTER SYSTEMS
K854220 10/18/1985 PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD PACESETTER SYSTEMS
K844792 12/10/1984 MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A PACESETTER SYSTEMS
K844851 12/13/1984 MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 PACESETTER SYSTEMS
K844857 12/14/1984 PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD PACESETTER SYSTEMS
K855081 12/19/1985 PHOENIX MODELS 250/251 PULSE GENERATORS PACESETTER SYSTEMS
K885267 12/22/1988 VS-1 MODEL NUMBER 251K PULSE GENERATOR PACESETTER SYSTEMS
K871208 03/25/1987 UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M PACESETTER SYSTEMS
K891905 03/27/1989 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE PACESETTER SYSTEMS
K861440 04/17/1986 LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO PACESETTER SYSTEMS
K861464 04/21/1986 LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS PACESETTER SYSTEMS
K861481 04/22/1986 ENDOCARDIAL CARBON-TIP LEAD PACESETTER SYSTEMS
K872779 07/14/1987 PROLOG MP PULSE GENERATORS 658K AND 658T PACESETTER SYSTEMS
K883087 07/21/1988 PROLOG MP 658M PULSE GENERATOR PACESETTER SYSTEMS
K895447 09/08/1989 ENDOCARDIAL SCREW-IN LEAD MODEL 1020T PACESETTER SYSTEMS
K853914 09/23/1985 PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI PACESETTER SYSTEMS
K874205 10/15/1987 ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T PACESETTER SYSTEMS
K884733 11/10/1988 AFP MODEL 262T PULSE GENERATOR PACESETTER SYSTEMS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact