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FDA 510(k)

A-18 HEMODIALYZER

K-Number: K992565 · 1999-09-23

ApplicantAlthin Medical AB
Decision Date1999-09-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

A-18 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K992565. 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 A-18 HEMODIALYZER?

A-18 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Althin Medical AB. The 510(k) number is K992565.

When did A-18 HEMODIALYZER receive FDA 510(k) clearance?

A-18 HEMODIALYZER received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992565.

Who is the listed applicant for A-18 HEMODIALYZER?

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

What is the FDA product code for A-18 HEMODIALYZER?

The FDA product code for A-18 HEMODIALYZER is FJI.

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Other records listing Althin Medical AB 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.

K992573AF-220 HEMODIALYZERK992566AF-150 HEMODIALYZERK992563A-22 HEMODIALYZERK992564AF-180 HEMODIALYZERK992594A-15 HEMODIALYZERK990010ALTHIN MEDICAL AB ALTRACART II

View all 7 devices →

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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