Endocardial Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Endocardial Solutions, Inc. makes
Endocardial Solutions, Inc. manufactures electrophysiology mapping systems, including the ENSTYLET catheter models (EC0010, EC0020) and the ENSITE 3000 system (model EE3000). These devices are designed for cardiac electrophysiology procedures, such as mapping and ablation of arrhythmias. The ENSITE system (model EE3000) and its modifications are also part of the portfolio, supporting intracardiac electrogram recording and catheter positioning.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) pathway. These systems are intended for use in electrophysiological studies and ablation therapies within the heart. The manufacturer is based in the United States.
Catalogue
Enstylet Models EC0010, EC0020 Ref K993376
Regimes: 510(k) Registry: 510(k)Ensite 3000 System Ref K992479
Regimes: 510(k) Registry: 510(k)Ensite System Ref K033211
Regimes: 510(k) Registry: 510(k)Ensite 3000 System, Model EE3000 Ref K001437
Regimes: 510(k) Registry: 510(k)Ensite System, Model EE3000 Ref K042493
Regimes: 510(k) Registry: 510(k)Modification To Ensite 3000 System, Model EE3000 Ref K012926
Regimes: 510(k) Registry: 510(k)Modification To Ensite 3000 System, Model EE3000 Ref K030129
Regimes: 510(k) Registry: 510(k)Ensite 3000 System Ref K983456
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Endocardial Solutions, Inc. have in the registry?
The registry currently lists 8 devices for Endocardial Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endocardial Solutions, Inc.'s devices?
Among its 8 most recently registered devices, Endocardial Solutions, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Endocardial Solutions, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Endocardial Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Endocardial Solutions, Inc. in the registry?
The most recently registered devices listed for Endocardial Solutions, Inc. include ENSTYLET MODELS EC0010, EC0020, ENSITE 3000 SYSTEM, ENSITE SYSTEM and ENSITE 3000 SYSTEM, MODEL EE3000.