Echocath, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Echocath, Inc. makes
Echocath, Inc. manufactures ultrasound-based medical devices for cardiac and vascular procedures, including the COLORMARK visualization system for real-time imaging, the ECHOMARK electrophysiology catheter for intracardiac mapping, and the ECHOFLOW Doppler systems for measuring blood flow velocity. The company also produces the ECHOMARK guidewire with ultrasonic localization and an intrauterine guiding catheter for procedural guidance.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Echocath, Inc. is based in the United States.
Catalogue
Colormark(Tm) Visualization System Ref K926351
Regimes: 510(k) Registry: 510(k)Echomark(R) Electrophysiology Catheter Ref K933417
Regimes: 510(k) Registry: 510(k)Echomark Guidewire With Ultrasonic Localization Ref K922787
Regimes: 510(k) Registry: 510(k)Echoflow Doppler Blood Velocity Meter Ref K990642
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Echomark Intrauterine Guiding Catheter Ref K932436
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Echocath, Inc. have in the registry?
The registry currently lists 6 devices for Echocath, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Echocath, Inc.'s devices?
Among its 6 most recently registered devices, Echocath, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Echocath, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Echocath, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Echocath, Inc. in the registry?
The most recently registered devices listed for Echocath, Inc. include COLORMARK(TM) VISUALIZATION SYSTEM, ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER, ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION and ECHOFLOW DOPPLER BLOOD VELOCITY METER.