Hemosphere, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Hemosphere, Inc. makes
Hemosphere, Inc. manufactures vascular access solutions, including the HERO Vascular Access Device and HERO Graft, designed for surgical and interventional procedures requiring controlled fluid pathways or graft integration.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Hero Vascular Access Device Ref K091491
Regimes: 510(k) Registry: 510(k)Hero Graft Ref K121532
Regimes: 510(k) Registry: 510(k)Hero Graft Ref K120006
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hemosphere, Inc. have in the registry?
The registry currently lists 3 devices for Hemosphere, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemosphere, Inc.'s devices?
Among its 3 most recently registered devices, Hemosphere, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Hemosphere, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hemosphere, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemosphere, Inc. in the registry?
The most recently registered devices listed for Hemosphere, Inc. include HERO VASCULAR ACCESS DEVICE and HERO GRAFT.