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FDA 510(k)

EXTERNAL Y VALVE 5C4198

K-Number: K870145 · 1987-03-10

ApplicantTravenol Laboratories, S.A.
Decision Date1987-03-10
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTERNAL Y VALVE 5C4198 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 1987-03-10 under 510(k) number K870145. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL Y VALVE 5C4198?

EXTERNAL Y VALVE 5C4198 is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K870145.

When did EXTERNAL Y VALVE 5C4198 receive FDA 510(k) clearance?

EXTERNAL Y VALVE 5C4198 received FDA 510(k) clearance on 1987-03-10, under 510(k) number K870145.

Who is the listed applicant for EXTERNAL Y VALVE 5C4198?

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 EXTERNAL Y VALVE 5C4198?

The FDA product code for EXTERNAL Y VALVE 5C4198 is KDJ.

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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: KDJ)

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.

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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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