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FDA 510(k)

TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2

K-Number: K850655 · 1985-03-07

ApplicantErika, Inc.
Decision Date1985-03-07
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1985-03-07 under 510(k) number K850655. 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 TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2?

TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 is a medical device that received FDA 510(k) clearance on 1985-03-07. The listed applicant is Erika, Inc.. The 510(k) number is K850655.

When did TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 receive FDA 510(k) clearance?

TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 received FDA 510(k) clearance on 1985-03-07, under 510(k) number K850655.

Who is the listed applicant for TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2?

The FDA 510(k) record lists Erika, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2?

The FDA product code for TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 is FJI.

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Other records listing Erika, Inc. 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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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

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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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