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FDA 510(k)

NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET

K-Number: K854517 · 1985-12-02

ApplicantTravenol Laboratories, S.A.
Decision Date1985-12-02
Product CodeFKK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET 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 1985-12-02 under 510(k) number K854517. The device is classified under product code FKK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET?

NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K854517.

When did NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET receive FDA 510(k) clearance?

NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET received FDA 510(k) clearance on 1985-12-02, under 510(k) number K854517.

Who is the listed applicant for NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET?

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 NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET?

The FDA product code for NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET is FKK.

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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: FKK)

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.

K854512TUBING CLAMP CAT#1000-ARao Medical Devices, Inc.K844121CLAMP, TUBING, LINEDyn-A-Med ProductsK831689EMPTY DIALYSATE CONTAINERDelmed, Inc.K822551AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, Inc.K802009FLOWCLAMP CAT.#1011 & 1012Pollak (Intl.), Ltd.

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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