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FDA 510(k)

EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210

K-Number: K030975 · 2003-04-25

ApplicantBaxter Healthcare Corp
Decision Date2003-04-25
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2003-04-25 under 510(k) number K030975. 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 EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210?

EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 is a medical device that received FDA 510(k) clearance on 2003-04-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K030975.

When did EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 receive FDA 510(k) clearance?

EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 received FDA 510(k) clearance on 2003-04-25, under 510(k) number K030975.

Who is the listed applicant for EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210?

The FDA product code for EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 is KDI.

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Other records listing Baxter Healthcare Corp as applicant

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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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