Flowmedica, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Flowmedica, Inc. makes
Flowmedica, Inc. manufactures bifurcated infusion systems, including infusion catheters and introducer sheaths designed for vascular access. These products are intended for use in medical procedures requiring dual-lumen access, such as dialysis or other infusion therapies. The portfolio includes specific models like the BENEPHIT bifurcated infusion catheter and 5Fr introducer sheath, as well as combined infusion system kits.
The company’s devices fall under FDA Class II regulation and are authorised via the 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, reflecting their compliance with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Flowmedica Benephit Infusion Systems Ref K082163
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Flowmedica, Inc. have in the registry?
The registry currently lists 3 devices for Flowmedica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flowmedica, Inc.'s devices?
Among its 3 most recently registered devices, Flowmedica, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Flowmedica, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Flowmedica, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Flowmedica, Inc. in the registry?
The most recently registered devices listed for Flowmedica, Inc. include FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH, BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH and FLOWMEDICA BENEPHIT INFUSION SYSTEMS.