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FDA 510(k), K210575, HDF Assist Mudule, HDF Infusion Set and Substitution Filter
FDA 510(k), K210575, HDF Assist Mudule, HDF Infusion Set and Substitution Filter
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$149.00 USD
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510(K) Number: K210575
Device Name: HDF Assist Mudule, HDF Infusion Set and Substitution Filter
Manufacturer: Nephros
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 02/26/2021
Decision Date: 05/13/2022
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HDF Assist Mudule, HDF Infusion Set and Substitution Filter
Manufacturer: Nephros
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 02/26/2021
Decision Date: 05/13/2022
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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