Hemoflow F3 and F4 Dialyzers
K-Number: K190459 · 2019-08-23
Device Summary
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. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K190459.
When did Hemoflow F3 and F4 Dialyzers receive FDA 510(k) clearance?
Hemoflow F3 and F4 Dialyzers received FDA 510(k) clearance on 2019-08-23, under 510(k) number K190459.
Who is the listed applicant for Hemoflow F3 and F4 Dialyzers?
The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.
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 records listing Fresenius Medical Care Renal Therapies Group, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.