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FDA 510(k)

HD CAPILLARY FILM DIALYZER, MODEL 1001

K-Number: K790533 · 1979-05-02

ApplicantTravenol Laboratories, S.A.
Decision Date1979-05-02
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD CAPILLARY FILM DIALYZER, MODEL 1001 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 1979-05-02 under 510(k) number K790533. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD CAPILLARY FILM DIALYZER, MODEL 1001?

HD CAPILLARY FILM DIALYZER, MODEL 1001 is a medical device that received FDA 510(k) clearance on 1979-05-02. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K790533.

When did HD CAPILLARY FILM DIALYZER, MODEL 1001 receive FDA 510(k) clearance?

HD CAPILLARY FILM DIALYZER, MODEL 1001 received FDA 510(k) clearance on 1979-05-02, under 510(k) number K790533.

Who is the listed applicant for HD CAPILLARY FILM DIALYZER, MODEL 1001?

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 HD CAPILLARY FILM DIALYZER, MODEL 1001?

The FDA product code for HD CAPILLARY FILM DIALYZER, MODEL 1001 is FJG.

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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: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.

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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