Ep Dynamics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Ep Dynamics, Inc. makes
Ep Dynamics, Inc. manufactures transseptal introducer sheaths, including the LINEBACKER™ series (53 cm, 62 cm, and 72 cm lengths) and the AIRBLOC series (53 cm Model FA001 and 72 cm Model FA002). These devices are designed for cardiac procedures requiring access across the atrial septum, such as ablation therapies.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. The devices are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Airbloc Transseptal Introducer, 53 Cm, Model FA001, Airblock Transseptal Introducer, 72 Cm, Model FA002 Ref K090867
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ep Dynamics, Inc. have in the registry?
The registry currently lists 2 devices for Ep Dynamics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ep Dynamics, Inc.'s devices?
Among its 2 most recently registered devices, Ep Dynamics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ep Dynamics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ep Dynamics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ep Dynamics, Inc. in the registry?
The most recently registered devices listed for Ep Dynamics, Inc. include LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM and AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM, MODEL FA002.