Company ยท US
Pacesetter Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1991. Name variants (Inc, Corp, punctuation) are merged.
96510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTB | Permanent Pacemaker Electrode | 33 |
| DXY | Implantable Pacemaker Pulse-Generator | 28 |
| DTD | Pacemaker Lead Adaptor | 20 |
| FRN | Pump, Infusion | 7 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DTG | Magnet, Test, Pacemaker | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| DYB | Introducer, Catheter | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 1 |
| KRG | Programmer, Pacemaker | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 1991 | K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE Pacesetter Systems | DTB |
| Jul 17, 1990 | K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T Pacesetter Systems | DTB |
| Jun 25, 1990 | K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS Pacesetter Systems | DTD |
| Apr 20, 1990 | K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T Pacesetter Systems | DTB |
| Dec 20, 1989 | K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T Pacesetter Systems | DTB |
| Jun 5, 1989 | K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Pacesetter Systems | DTB |
| Mar 28, 1989 | K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR Pacesetter Systems | DXY |
| Mar 22, 1989 | K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS Pacesetter Systems | DTB |
| Feb 10, 1989 | K884733 | AFP MODEL 262T PULSE GENERATOR Pacesetter Systems | DXY |
| Sep 14, 1988 | K883087 | PROLOG MP 658M PULSE GENERATOR Pacesetter Systems | DXY |
| Feb 2, 1988 | K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T Pacesetter Systems | DTB |
| Nov 4, 1987 | K872779 | PROLOG MP PULSE GENERATORS 658K AND 658T Pacesetter Systems | DXY |
| Oct 22, 1987 | K873931 | MODIFIED MODELS 1025M & 1026T PACING LEAD Pacesetter Systems | DTB |
| Jun 5, 1987 | K871208 | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M Pacesetter Systems | DYB |
| Mar 20, 1987 | K870824 | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 Pacesetter Systems | DTB |
| Feb 3, 1987 | K862226 | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS Pacesetter Systems | DXY |
| Jun 26, 1986 | K861422 | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY Pacesetter Systems | DXY |
| Jun 9, 1986 | K861436 | SOF SET, MODELS 111 AND 112 Pacesetter Systems | FRN |
| Jun 6, 1986 | K861481 | ENDOCARDIAL CARBON-TIP LEAD Pacesetter Systems | DTB |
| May 27, 1986 | K860857 | SOF SET, MODELS 113 AND 114 Pacesetter Systems | FRN |
| May 19, 1986 | K861464 | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS Pacesetter Systems | DTB |
| May 13, 1986 | K861440 | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO Pacesetter Systems | DTB |
| May 2, 1986 | K861140 | PROGRAMALITH III PULSE GENERATOR Pacesetter Systems | DXY |
| Apr 23, 1986 | K860546 | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 Pacesetter Systems | KRG |
| Mar 7, 1986 | K855081 | PHOENIX MODELS 250/251 PULSE GENERATORS Pacesetter Systems | DXY |
| Jan 7, 1986 | K854195 | PROGRAMALITH III MODELS 238 & 239 Pacesetter Systems | DXY |
| Dec 4, 1985 | K854405 | PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD Pacesetter Systems | DTB |
| Dec 4, 1985 | K854220 | PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD Pacesetter Systems | DTB |
| Dec 3, 1985 | K853914 | PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI Pacesetter Systems | DTB |
| May 21, 1985 | K851665 | PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE Pacesetter Systems | DTD |
| May 16, 1985 | K851861 | PROGRAMALITH III MODEL 249 PULSE GENERATOR Pacesetter Systems | DXY |
| May 15, 1985 | K850464 | PROGRAMALITH III 240 PULSE GENERATOR Pacesetter Systems | DXY |
| Apr 19, 1985 | K851145 | PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD Pacesetter Systems | DTD |
| Apr 10, 1985 | K850652 | PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD Pacesetter Systems | DTD |
| Apr 1, 1985 | K850651 | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR Pacesetter Systems | DXY |
| Mar 6, 1985 | K850576 | PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR Pacesetter Systems | DTD |
| Feb 14, 1985 | K844857 | PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD Pacesetter Systems | DTD |
| Jan 22, 1985 | K844851 | MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 Pacesetter Systems | FRN |
| Jan 22, 1985 | K844792 | MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A Pacesetter Systems | FRN |
| Jan 10, 1985 | K844334 | VIVALITH II 301 PULSE GENERATOR Pacesetter Systems | DXY |
| Jan 8, 1985 | K843703 | PERMATHANE 865 & 867 UNIPOLAR POLYURETH Pacesetter Systems | DTD |
| Aug 3, 1984 | K841885 | FASTPASS IMPLANTABLE ENDOCARDIAL PAC Pacesetter Systems | DTD |
| Aug 3, 1984 | K841739 | MODEL 866 PERMATHANE BIPOLAR, COAXIAL Pacesetter Systems | DTD |
| Mar 12, 1984 | K834431 | PACING ELECTRODE Pacesetter Systems | DTB |
| Dec 21, 1983 | K830016 | VASCUTEK VASCULAR PROTHESIS VP1200K/50K Pacesetter Systems | DSY |
| Dec 16, 1983 | K833647 | PACEMAKER SYS ANALYZER #384 Pacesetter Systems | KRE |
| Dec 1, 1983 | K833824 | ENDOCARDIAL SCREW-IN LEAD 859 & 861 Pacesetter Systems | DTB |
| Oct 20, 1983 | K832987 | PERMANTHANE #866 BIPOLAR COAXIAL Pacesetter Systems | DTB |
| Sep 12, 1983 | K831445 | INFUSION SETS #'S 124 & 142 PERSONAL Pacesetter Systems | FPA |
| Sep 12, 1983 | K831444 | SINGLE USE SYRINGE #103 PERSONAL MEDIC Pacesetter Systems | FRN |
Newest 50 of 96.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||