Siemens-Pacesetter, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Siemens-Pacesetter, Inc. makes
Siemens-Pacesetter, Inc. manufactures cardiac pacing systems and associated leads, including transvenous pacing leads (e.g., Model 1188T, Model 1148T), silicone bipolar leads (e.g., Models 1136T, 1142T, 1146T), and passive-fixation endocardial pacing leads. Their portfolio also includes permanent pacemaker electrodes and accessories like adapting sleeve kits (e.g., Model 4023) for implantation procedures.
The company’s devices fall under FDA Class II and Class III classifications, with regulatory submissions recorded in the FDA 510(k) database. These products are intended for cardiovascular applications, including pacemaker-based rhythm management. The manufacturer is based in the United States.
Catalogue
Afp Cardiac Pacing System Model 283 Ref K942440
Regimes: 510(k) Registry: 510(k)Pacing Lead Model 1188T Ref K925038
Regimes: 510(k) Registry: 510(k)Silicone Bipolar Lead Models 1136T, 1142T &1146T Ref K930876
Regimes: 510(k) Registry: 510(k)Adapting Sleeve Kit Model 4023 Ref K921318
Regimes: 510(k) Registry: 510(k)Model 1148T Transvenous, Screw-In Lead Ref K925347
Regimes: 510(k) Registry: 510(k)Cardiovascular Permanent Pacemaker Electrode Ref K920822
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Siemens-Pacesetter, Inc. have in the registry?
The registry currently lists 7 devices for Siemens-Pacesetter, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens-Pacesetter, Inc.'s devices?
Among its 7 most recently registered devices, Siemens-Pacesetter, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Siemens-Pacesetter, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Siemens-Pacesetter, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Siemens-Pacesetter, Inc. in the registry?
The most recently registered devices listed for Siemens-Pacesetter, Inc. include AFP CARDIAC PACING SYSTEM MODEL 283, PACING LEAD MODEL 1188T, SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T and ADAPTING SLEEVE KIT MODEL 4023.