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FDA 510(k)

NXSTAGE 1.6M2 DIALYZER

K-Number: K131050 · 2013-12-27

ApplicantNxstage Medical, Inc.
Decision Date2013-12-27
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NXSTAGE 1.6M2 DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2013-12-27 under 510(k) number K131050. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NXSTAGE 1.6M2 DIALYZER?

NXSTAGE 1.6M2 DIALYZER is a medical device that received FDA 510(k) clearance on 2013-12-27. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K131050.

When did NXSTAGE 1.6M2 DIALYZER receive FDA 510(k) clearance?

NXSTAGE 1.6M2 DIALYZER received FDA 510(k) clearance on 2013-12-27, under 510(k) number K131050.

Who is the listed applicant for NXSTAGE 1.6M2 DIALYZER?

The FDA 510(k) record lists Nxstage Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NXSTAGE 1.6M2 DIALYZER?

The FDA product code for NXSTAGE 1.6M2 DIALYZER is KDI.

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Other records listing Nxstage Medical, Inc. 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.

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow SolutionK230632VersiHD with GuideMe softwareK183158NxStage Cartridge Express with SpeedswapK181991NxStage Connected Health SystemK171331NxStage System One

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius 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.

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