Pacesetter Systems
Mchenry, IL, US
Pacesetter Systems appears in FDA device records in Mchenry, IL. FDA records list 96 510(k) clearances between and , 19 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 96
- PMA records
- 19
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 96FDA records hold 96 510(k) clearances for Pacesetter Systems between 1976 and 1991. The busiest year on record is 1985, with 15. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 5 |
| 1980 | 6 |
| 1981 | 13 |
| 1982 | 6 |
| 1983 | 14 |
| 1984 | 3 |
| 1985 | 15 |
| 1986 | 10 |
| 1987 | 5 |
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 3 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | DTB | Substantially Equivalent | |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | DTB | Substantially Equivalent | |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | DTD | Substantially Equivalent | |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | DTB | Substantially Equivalent | |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | DTB | Substantially Equivalent | |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | DTB | Substantially Equivalent | |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | DXY | Substantially Equivalent | |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | DTB | Substantially Equivalent | |
| K884733 | AFP MODEL 262T PULSE GENERATOR | DXY | Substantially Equivalent | |
| K883087 | PROLOG MP 658M PULSE GENERATOR | DXY | Substantially Equivalent | |
| K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T | DTB | Substantially Equivalent | |
| K872779 | PROLOG MP PULSE GENERATORS 658K AND 658T | DXY | Substantially Equivalent | |
| K873931 | MODIFIED MODELS 1025M & 1026T PACING LEAD | DTB | Substantially Equivalent | |
| K871208 | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M | DYB | Substantially Equivalent | |
| K870824 | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 | DTB | Substantially Equivalent | |
| K862226 | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS | DXY | Substantially Equivalent | |
| K861422 | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY | DXY | Substantially Equivalent | |
| K861436 | SOF SET, MODELS 111 AND 112 | FRN | Substantially Equivalent | |
| K861481 | ENDOCARDIAL CARBON-TIP LEAD | DTB | Substantially Equivalent | |
| K860857 | SOF SET, MODELS 113 AND 114 | FRN | Substantially Equivalent | |
| K861464 | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS | DTB | Substantially Equivalent | |
| K861440 | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO | DTB | Substantially Equivalent | |
| K861140 | PROGRAMALITH III PULSE GENERATOR | DXY | Substantially Equivalent | |
| K860546 | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 | KRG | Substantially Equivalent | |
| K855081 | PHOENIX MODELS 250/251 PULSE GENERATORS | DXY | Substantially Equivalent | |
| K854195 | PROGRAMALITH III MODELS 238 & 239 | DXY | Substantially Equivalent | |
| K854405 | PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD | DTB | Substantially Equivalent | |
| K854220 | PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD | DTB | Substantially Equivalent | |
| K853914 | PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI | DTB | Substantially Equivalent | |
| K851665 | PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE | DTD | Substantially Equivalent | |
| K851861 | PROGRAMALITH III MODEL 249 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K850464 | PROGRAMALITH III 240 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K851145 | PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD | DTD | Substantially Equivalent | |
| K850652 | PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD | DTD | Substantially Equivalent | |
| K850651 | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K850576 | PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR | DTD | Substantially Equivalent | |
| K844857 | PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD | DTD | Substantially Equivalent | |
| K844851 | MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 | FRN | Substantially Equivalent | |
| K844792 | MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A | FRN | Substantially Equivalent | |
| K844334 | VIVALITH II 301 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K843703 | PERMATHANE 865 & 867 UNIPOLAR POLYURETH | DTD | Substantially Equivalent | |
| K841885 | FASTPASS IMPLANTABLE ENDOCARDIAL PAC | DTD | Substantially Equivalent | |
| K841739 | MODEL 866 PERMATHANE BIPOLAR, COAXIAL | DTD | Substantially Equivalent | |
| K834431 | PACING ELECTRODE | DTB | Substantially Equivalent | |
| K830016 | VASCUTEK VASCULAR PROTHESIS VP1200K/50K | DSY | Substantially Equivalent | |
| K833647 | PACEMAKER SYS ANALYZER #384 | KRE | Substantially Equivalent | |
| K833824 | ENDOCARDIAL SCREW-IN LEAD 859 & 861 | DTB | Substantially Equivalent | |
| K832987 | PERMANTHANE #866 BIPOLAR COAXIAL | DTB | Substantially Equivalent | |
| K831445 | INFUSION SETS #'S 124 & 142 PERSONAL | FPA | Substantially Equivalent | |
| K831444 | SINGLE USE SYRINGE #103 PERSONAL MEDIC | FRN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KREAnalyzer, Pacemaker Generator Function, Indirect
- DXYImplantable Pacemaker Pulse-Generator
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)
- DYBIntroducer, Catheter
- DTGMagnet, Test, Pacemaker
- KNGMonitor, Ultrasonic, Fetal
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
- KRGProgrammer, Pacemaker
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain