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