Apollon Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Apollon Co., Ltd. makes
Apollon Co., Ltd. manufactures Foley balloon catheters designed for urological procedures, including drainage and bladder management in clinical settings.
The company’s Foley balloon catheter is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The product is registered in the United States.
Catalogue
Foley Balloon Catheter for Urology Ref K201776
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apollon Co., Ltd. have in the registry?
The registry currently lists 1 device for Apollon Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apollon Co., Ltd.'s devices?
Among its 1 most recently registered device, Apollon Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Apollon Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Apollon Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apollon Co., Ltd. in the registry?
The most recently registered devices listed for Apollon Co., Ltd. include Foley Balloon Catheter for Urology.