Bellco Artifidial Organ Spec., Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bellco Artifidial Organ Spec., Inc. makes
Bellco Artificial Organ Specialties, Inc. manufactures single-use hemodialysis devices, including the Vita 2 Disposable Dialyzer, which filters blood to remove waste and excess fluids in patients with kidney failure. The company also produces Bellco Fistula Needles, designed for vascular access in dialysis procedures, and the Bravo New Parallel Flow Dialyzer, a hemodialysis device optimized for efficient blood purification.
The company’s portfolio consists of Class II medical devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under the FDA’s 510(k) premarket notification process and are intended for use in the United States. The manufacturer is based in the US.
Catalogue
The Vita 2 Disposable Dialyzer Ref K801634
Regimes: 510(k) Registry: 510(k)The Bellco Fistula Needles Ref K801632
Regimes: 510(k) Registry: 510(k)The Bravo New Parallel Flow Dialyzer Ref K801633
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bellco Artifidial Organ Spec., Inc. have in the registry?
The registry currently lists 3 devices for Bellco Artifidial Organ Spec., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bellco Artifidial Organ Spec., Inc.'s devices?
Among its 3 most recently registered devices, Bellco Artifidial Organ Spec., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bellco Artifidial Organ Spec., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bellco Artifidial Organ Spec., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bellco Artifidial Organ Spec., Inc. in the registry?
The most recently registered devices listed for Bellco Artifidial Organ Spec., Inc. include THE VITA 2 DISPOSABLE DIALYZER, THE BELLCO FISTULA NEEDLES and THE BRAVO NEW PARALLEL FLOW DIALYZER.