Renal Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 35
What Renal Systems, Inc. makes
Renal Systems, Inc. manufactures vascular access devices for hemodialysis, including the RENALLOY and HEMASITE graftless vascular access shunts, as well as hollow fiber dialyzers like the PRIMUS series and RENAFLO models. The company also produces hemodialysis concentrates, disinfectants such as ACTRIL, and specialized filtration systems like the RENALFO hemofilter for continuous arteriovenous hemodiafiltration (CAVHD). Additional offerings include the RS-7800 minipump, dialysate concentrate formulations, and accessory modifications for vascular access.
The company’s products are classified under FDA’s Class II regulatory category and are listed via 510(k) clearance in the United States. All devices are subject to FDA compliance requirements for hemodialysis-related equipment and accessories. The manufacturer operates from the US.
Catalogue
Search and filter all 35 devicesFrequently asked questions
How many devices does Renal Systems, Inc. have in the registry?
The registry currently lists 35 devices for Renal Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Renal Systems, Inc.'s devices?
Among its 35 most recently registered devices, Renal Systems, Inc. has devices listed in FDA 510(k) (35 devices).
What risk classes do Renal Systems, Inc.'s devices fall under?
Among its 35 most recently registered devices, the classes recorded for Renal Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Renal Systems, Inc. in the registry?
The most recently registered devices listed for Renal Systems, Inc. include RENALLOY HEMASITE VASCULAR ACCESS SHUNT, PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000, 1000S, 1350, 1350S, 2000, 2000S), HEMASITE GRAFTLESS VASCULAR ACESS and ACTRIL FOR KIDNEY MACHINE DISINFECTANT.