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FDA 510(k)

ST FAMILY OF HOLLOW FIBER DIALYZERS

K-Number: K844756 · 1985-01-16

ApplicantTravenol Laboratories, S.A.
Decision Date1985-01-16
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ST FAMILY OF HOLLOW FIBER DIALYZERS 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 1985-01-16 under 510(k) number K844756. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST FAMILY OF HOLLOW FIBER DIALYZERS?

ST FAMILY OF HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 1985-01-16. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K844756.

When did ST FAMILY OF HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

ST FAMILY OF HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 1985-01-16, under 510(k) number K844756.

Who is the listed applicant for ST FAMILY OF HOLLOW FIBER DIALYZERS?

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 ST FAMILY OF HOLLOW FIBER DIALYZERS?

The FDA product code for ST FAMILY OF HOLLOW FIBER DIALYZERS is FKQ.

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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: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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