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FDA 510(k)

MCA(TM) 160 HEMODIALYZER

K-Number: K945624 · 1995-05-18

ApplicantAlthin Medical AB an Affiliate of Baxter Intl
Decision Date1995-05-18
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MCA(TM) 160 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 1995-05-18 under 510(k) number K945624. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCA(TM) 160 HEMODIALYZER?

MCA(TM) 160 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K945624.

When did MCA(TM) 160 HEMODIALYZER receive FDA 510(k) clearance?

MCA(TM) 160 HEMODIALYZER received FDA 510(k) clearance on 1995-05-18, under 510(k) number K945624.

Who is the listed applicant for MCA(TM) 160 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 MCA(TM) 160 HEMODIALYZER?

The FDA product code for MCA(TM) 160 HEMODIALYZER is FJI.

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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: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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