Pacesetter, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Pacesetter, Inc. makes
Pacesetter, Inc. manufactures cardiac pacing leads, including unipolar endocardial screw-in leads like the TENDRIL and passive plus pacing leads with titanium nitride coatings. Their portfolio also includes terminal caps (e.g., DF-1 and IS-1/quadripolar) and specialized systems, such as the AFP cardiac pacing system. Additionally, they produce nebulizers, including the Siemens Servo Ultra Nebulizer 345, designed for respiratory therapy applications.
The company’s devices are regulated under FDA Class II and Class III classifications, with many authorised via the 510(k) pathway. Their products are listed in the FDA’s 510(k) database. Pacesetter, Inc. is based in the United States.
Catalogue
Locator Model 4036 Ref K972814
Regimes: 510(k) Registry: 510(k)Tendril, Unipolar Endocardial Screw-In Lead Ref K951087
Regimes: 510(k) Registry: 510(k)Df-1 Terminal Cap Ref K954551
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Siemens Servo Ultra Nebulizer 345 Ref K960854
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pacesetter, Inc. have in the registry?
The registry currently lists 8 devices for Pacesetter, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacesetter, Inc.'s devices?
Among its 8 most recently registered devices, Pacesetter, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Pacesetter, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for 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 Pacesetter, Inc. in the registry?
The most recently registered devices listed for Pacesetter, Inc. include LOCATOR MODEL 4036, TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, DF-1 TERMINAL CAP and IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069.