Pacesetter Systems

Country not established

Devices: 98

What Pacesetter Systems makes

The company manufactures vascular prostheses, including the VASCUTEK VP1200K/50K for blood vessel replacement, and cardiovascular pacing devices such as permanent pacemaker electrodes, unipolar/bipolar pacing leads, and implantable endocardial pacemakers like the FASTPASS and FIRM LEAD. It also produces connector adapters for pacemakers, a personal medication infuser, and specialized pacing components such as the PACEMAKER CONNECTOR PLUG and PERMANTHANE bipolar coaxial lead.

The portfolio includes devices regulated under FDA Class I, II, and III classifications, with authorisation records in the 510(k) and PMA pathways. These products are listed in the US under FDA regulatory frameworks, and the company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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What Pacesetter Systems makes

Catalogue98

Mdl-201A & T Dl-201A Pulse Generator Ref K790428

Endocardial Screw-In Lead Model 1028T Ref K902147

Vs-1 Model Number 251K Pulse Generator Ref K885267

Afp Pulse Generator Ref K823559

Pacepath Implant. Endocard. Pacing Lead Ref K810286

Siemens Elema Models 4020T And 4021T Adapters Ref K900512

Programalith Programmer Ref K823242

Pacesetter Systems, Model 458 Adapter Sleeve Ref K851665

Pacesetter Systems Endocardial Small Fin Lead Ref K854405

Dialog Programmer 700 - Program Version 6.37 Ref K860546

Adapting Sleeve Ref K813154

Ventricular Pacing Leads Models 865/867 Ref K831435

Modified Models 1025M & 1026T Pacing Lead Ref K873931

Programalith Iii Model 249 Pulse Generator Ref K851861

Pacesetter Systems Inc. Endocardial Finned Lead Ref K851145

Pacesetter Sysems Endocardial Tri-Fix Lead Ref K854220

Pacing Leads Model Ul-811 And Ul-813 Ref K781776

Siemens Elema Models 4025 And 4026 Adapters Ref K890547

Pacemaker Sys Analyzer #384 Ref K833647

Adapter A-413 Ref K771642

Programalith Iii 240 Pulse Generator Ref K850464

Unipolar Endocardial Screw-In Lead, Model 1007M Ref K871208

Pacepath Model 810 Ref K801416

Model 866 Permathane Bipolar, Coaxial Ref K841739

Electrode, Pacemaker Permanent Ref K810582

Lead, Endocardial, Tined, Bipolar, 5mm Ref K801455

Unipolar Atrial J Pacing Lead Model 869 Ref K831436

Model 100 Cardiac Pacemaker Ref K760757

Universal Lead Adapter, Ua-414 Ref K771641

Model 833 Endocardial Tined Lead Ref K812815

Vitatron Insert Ref K813151

Electrode, Pacemaker, Permanent Ref K823033

Pulse Generator, R Wave Demand Ref K790141

Pacepath Implantable Endocard. Pacing Ld Ref K811200

Fast-Pass Ace Models 1212T/1222T/1216T/1226T Ref K900550

Vivalith Ii 301 Pulse Generator Ref K844334

Generators: Udl-201B, Bdl-201B, Mdl-201B Ref K781424

Pacemaker Lead Adaptor Model 431 Ref K802407

Electrode, Pacemaker, Permanent Ref K810139

Minimed External Infusion Pump For Diabetics 502A Ref K844792

Personal Medication Infuser Ref K810850

Sof Set, Models 111 And 112 Ref K861436

Programalith Iii Pulse Generator Ref K861140

Model 841 Endocardial Tined Lead Ref K812816

Mdl-201 Ref K772051

Ddd Pulse Generator 674 Ref P840014

Programalith(Tm) Model 223 Pulse Generator & 398 P Ref P820023

Endocardial Pacemaker Lead W/Carbon Tip Ref K861481