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FDA 510(k)

CLIRANS HOLLOW FIBER HEMODIALYZER (WET)

K-Number: K891477 · 1989-06-09

ApplicantTerumo Medical Corp.
Decision Date1989-06-09
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIRANS HOLLOW FIBER HEMODIALYZER (WET) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891477. 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 HOLLOW FIBER HEMODIALYZER (WET)?

CLIRANS HOLLOW FIBER HEMODIALYZER (WET) is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Terumo Medical Corp.. The 510(k) number is K891477.

When did CLIRANS HOLLOW FIBER HEMODIALYZER (WET) receive FDA 510(k) clearance?

CLIRANS HOLLOW FIBER HEMODIALYZER (WET) received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891477.

Who is the listed applicant for CLIRANS HOLLOW FIBER HEMODIALYZER (WET)?

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

What is the FDA product code for CLIRANS HOLLOW FIBER HEMODIALYZER (WET)?

The FDA product code for CLIRANS HOLLOW FIBER HEMODIALYZER (WET) is FJI.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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