Goodman Co., Ltd.
Country not established
- Devices
- 4
What Goodman Co., Ltd. makes
Goodman Co., Ltd. manufactures peripheral angioplasty balloon catheters designed for basic percutaneous transluminal angioplasty (PTA) procedures. Their product line includes the Aperta NSE™ PTA Balloon Dilatation Catheter, intended for dilating narrowed or obstructed arteries in peripheral vascular applications.
The company’s devices are classified as Class II and Class III under regulatory frameworks, with records submitted to the FDA via 510(k), PMA, and UDI listings. The manufacturer is based in Japan and adheres to these regulatory requirements for market authorisation.
Catalogue
Aperta NSE PTA Balloon Dilatation Catheter Ref K243944
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Goodnet Ref K010763
Regimes: 510(k) Registry: 510(k)Lacrosse NSE ALPHA Coronary Dilatation Catheter Ref P230026
Regimes: PMA Registry: PMA
Company details
- DUNS number
- 690965116
- [email protected]
- Phone
- 800-596-3104
Frequently asked questions
How many devices does Goodman Co., Ltd. have in the registry?
The registry currently lists 4 devices for Goodman Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Goodman Co., Ltd.'s devices?
Among its 4 most recently registered devices, Goodman Co., Ltd. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Goodman Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Goodman Co., Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Goodman Co., Ltd. in the registry?
The most recently registered devices listed for Goodman Co., Ltd. include Aperta NSE PTA Balloon Dilatation Catheter, Aperta NSE PTA Balloon Dilatation Catheter (AA18-05040040), GOODNET and Lacrosse NSE ALPHA Coronary Dilatation Catheter.