Hemoflow F3 and F4 Dialyzers
K-Number: K190459 · 2019-08-23
Decision Date2019-08-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Hemoflow F3 and F4 Dialyzers is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2019-08-23 under approval number K190459. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hemoflow F3 and F4 Dialyzers?
Hemoflow F3 and F4 Dialyzers is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K190459.
When was Hemoflow F3 and F4 Dialyzers approved by the FDA?
Hemoflow F3 and F4 Dialyzers received FDA 510(k) clearance on 2019-08-23, under approval number K190459.
What company makes Hemoflow F3 and F4 Dialyzers?
Hemoflow F3 and F4 Dialyzers is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for Hemoflow F3 and F4 Dialyzers?
The FDA product code for Hemoflow F3 and F4 Dialyzers is FJI.
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.