American Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What American Technology, Inc. makes
American Technology, Inc. manufactures endocardial pacing leads, including unipolar and bipolar designs, for cardiac catheter-based procedures. These leads are intended for use with implantable cardiac pacemakers to stimulate the heart’s inner lining.
The company’s products fall under FDA Class III regulation and are recorded in the 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
Catheter, Cardiac Pacing, Endocardial Ref K771528
Regimes: 510(k) Registry: 510(k)Endocardial Bipolar Lead Ref K781456
Regimes: 510(k) Registry: 510(k)Unipoplar Endocardial Leads Ref K781326
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Technology, Inc. have in the registry?
The registry currently lists 3 devices for American Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Technology, Inc.'s devices?
Among its 3 most recently registered devices, American Technology, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do American Technology, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for American Technology, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from American Technology, Inc. in the registry?
The most recently registered devices listed for American Technology, Inc. include CATHETER, CARDIAC PACING, ENDOCARDIAL, ENDOCARDIAL BIPOLAR LEAD and UNIPOPLAR ENDOCARDIAL LEADS.