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FDA 510(k)

CF/211 CAPILLARY FLOW DIALYZER, #5M1784

K-Number: K800221 · 1980-02-26

ApplicantTravenol Laboratories, S.A.
Decision Date1980-02-26
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CF/211 CAPILLARY FLOW DIALYZER, #5M1784 is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800221. 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 CF/211 CAPILLARY FLOW DIALYZER, #5M1784?

CF/211 CAPILLARY FLOW DIALYZER, #5M1784 is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K800221.

When did CF/211 CAPILLARY FLOW DIALYZER, #5M1784 receive FDA 510(k) clearance?

CF/211 CAPILLARY FLOW DIALYZER, #5M1784 received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800221.

Who is the listed applicant for CF/211 CAPILLARY FLOW DIALYZER, #5M1784?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CF/211 CAPILLARY FLOW DIALYZER, #5M1784?

The FDA product code for CF/211 CAPILLARY FLOW DIALYZER, #5M1784 is FJI.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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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