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FDA 510(k)

HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R

K-Number: K914790 · 1993-03-05

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1993-03-05
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K914790. 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 HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R?

HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K914790.

When did HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R received FDA 510(k) clearance on 1993-03-05, under 510(k) number K914790.

Who is the listed applicant for HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R?

The FDA product code for HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R is FJI.

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Other records listing National Medical Care, Medical Products Div., 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.

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETK941757FORMALIN REUSE CARTK952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERK930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000K920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPK920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9

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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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