Acumen Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Acumen Medical, Inc. makes
Acumen Medical, Inc. manufactures single-lumen delivery sheaths for cardiac procedures, including modified versions for specific applications such as lead delivery with stylet compatibility. The company also produces endocardial visualization systems, including coronary sinus visualization catheters designed for imaging within the heart’s venous structures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Acumen Medical, Inc. have in the registry?
The registry currently lists 12 devices for Acumen Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acumen Medical, Inc.'s devices?
Among its 12 most recently registered devices, Acumen Medical, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Acumen Medical, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Acumen Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acumen Medical, Inc. in the registry?
The most recently registered devices listed for Acumen Medical, Inc. include ACUMEN SINGLE-LUMEN DELIVERY SHEATH, ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM, MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 and 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67.