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FDA 510(k)

CLIRANS TE10 HOLLOW FIBER DIALYZER

K-Number: K801192 · 1980-08-12

ApplicantTerumo America, Inc.
Decision Date1980-08-12
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIRANS TE10 HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1980-08-12 under 510(k) number K801192. 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 CLIRANS TE10 HOLLOW FIBER DIALYZER?

CLIRANS TE10 HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Terumo America, Inc.. The 510(k) number is K801192.

When did CLIRANS TE10 HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

CLIRANS TE10 HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801192.

Who is the listed applicant for CLIRANS TE10 HOLLOW FIBER DIALYZER?

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

What is the FDA product code for CLIRANS TE10 HOLLOW FIBER DIALYZER?

The FDA product code for CLIRANS TE10 HOLLOW FIBER DIALYZER is FJI.

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Other records listing Terumo America, 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZER

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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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