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FDA 510(k)

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM

K-Number: K954987 · 1996-08-08

ApplicantAlthin Medical AB an Affiliate of Baxter Intl
Decision Date1996-08-08
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM 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 1996-08-08 under 510(k) number K954987. 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 ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM?

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K954987.

When did ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM receive FDA 510(k) clearance?

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM received FDA 510(k) clearance on 1996-08-08, under 510(k) number K954987.

Who is the listed applicant for ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM?

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 ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM?

The FDA product code for ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM 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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