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FDA 510(k)

ALTREX(R) 200 HEMODIALYZER

K-Number: K945595 · 1995-03-08

ApplicantAlthin Medical AB an Affiliate of Baxter Intl
Decision Date1995-03-08
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALTREX(R) 200 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. It received FDA 510(k) clearance on 1995-03-08 under 510(k) number K945595. 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 ALTREX(R) 200 HEMODIALYZER?

ALTREX(R) 200 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1995-03-08. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K945595.

When did ALTREX(R) 200 HEMODIALYZER receive FDA 510(k) clearance?

ALTREX(R) 200 HEMODIALYZER received FDA 510(k) clearance on 1995-03-08, under 510(k) number K945595.

Who is the listed applicant for ALTREX(R) 200 HEMODIALYZER?

The FDA 510(k) record lists Althin Medical AB an Affiliate of Baxter Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTREX(R) 200 HEMODIALYZER?

The FDA product code for ALTREX(R) 200 HEMODIALYZER is KDI.

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Other records listing Althin Medical AB an Affiliate of Baxter Intl 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.

K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015K970679ALTRA FLUX 200 HEMODIALYZERK970681ALTRA NOVA 200 HEMODIALYZERK970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMK964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEMK955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

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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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