SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)— 510(k) K242269

Name: FDA 510(k) clearance K242269
Creator: U.S. Food and Drug Administration
Published: 2024-11-01

Substantially Equivalent

Quanta Dialysis Technologies, Ltd.

FDA 510(k) clearance K242269 for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651), Substantially Equivalent on 2024-11-01. Applicant: Quanta Dialysis Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Quanta Dialysis Technologies, Ltd.
Product code: Code ONW
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2024-08-01
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, GB

Download summary PDF View on FDA.gov ↗

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K124035 — 2008K@HOME HEMODIALYSIS MACHINE2013-07-03
K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)2013-01-17
K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR2011-02-03

More clearances from Quanta Dialysis Technologies, Ltd.

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K222067 — SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set2022-11-10
K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset2021-08-12
K193670 — SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set2020-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.