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FDA 510(k)

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

K-Number: K982337 · 1998-12-29

ApplicantHaidylena Medical Egypt
Decision Date1998-12-29
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Haidylena Medical Egypt. It received FDA 510(k) clearance on 1998-12-29 under 510(k) number K982337. 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 CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER?

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1998-12-29. The listed applicant is Haidylena Medical Egypt. The 510(k) number is K982337.

When did CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1998-12-29, under 510(k) number K982337.

Who is the listed applicant for CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER?

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

What is the FDA product code for CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER?

The FDA product code for CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER is FJI.

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Other records listing Haidylena Medical Egypt 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.

K982340EXTRACORPOREAL BLOOD CIRCUIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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