Polyflux Family Hemodialyzer/Filter Labeled For Single And Multiple Use (14l +7…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043342

Identifiers

510(k) Number: K043342 FDA 510(k)
FDA Product Code: FJI FDA 510(k)
Models / Variants: 14l FDA 510(k)
17l FDA 510(k)
21l FDA 510(k)
140h FDA 510(k)
170h FDA 510(k)
210h FDA 510(k)
6lr FDA 510(k)
8lr FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.5820 FDA 510(k)
Regulation Number: 876.5820 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Polyflux Family Hemodialyzer/Filter Labeled For Single And Multiple Use (14l +7… by Gambro Renal Products — Class II — FDA_510K — listed in FDA 510(k) — 8…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K043342	Class II	Active

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Manufacturer

Manufacturer: Gambro Renal Products

Sources (1)

FDA 510(k) K043342 24 fields · synced Jun 18, 2026