American Heartline, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What American Heartline, Inc. makes
American Heartline, Inc. manufactures medical devices including the DISK, a blood processing system, and the VITALINE 2, a patient monitoring and infusion device designed for critical care environments.
The company’s products are regulated under the FDA’s 510(k) clearance process, indicating they meet U.S. safety and performance requirements. These devices are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Disk Ref K812695
Regimes: 510(k) Registry: 510(k)Vitaline 2 Ref K822856
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Heartline, Inc. have in the registry?
The registry currently lists 2 devices for American Heartline, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Heartline, Inc.'s devices?
Among its 2 most recently registered devices, American Heartline, Inc. has devices listed in FDA 510(k) (2 devices).
What are the newest devices from American Heartline, Inc. in the registry?
The most recently registered devices listed for American Heartline, Inc. include DISK and VITALINE 2.