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FDA 510(k)

DISSCAP HOLLOW FIBER DIALYZER

K-Number: K802466 · 1980-11-12

ApplicantHospal Medical Corp.
Decision Date1980-11-12
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISSCAP HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802466. 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 DISSCAP HOLLOW FIBER DIALYZER?

DISSCAP HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Hospal Medical Corp.. The 510(k) number is K802466.

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

DISSCAP HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802466.

Who is the listed applicant for DISSCAP HOLLOW FIBER DIALYZER?

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

What is the FDA product code for DISSCAP HOLLOW FIBER DIALYZER?

The FDA product code for DISSCAP HOLLOW FIBER DIALYZER is FJI.

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Other records listing Hospal 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.

K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZERK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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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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