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FDA 510(k)

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY

K-Number: K761287 · 1977-01-03

ApplicantTravenol Laboratories, S.A.
Decision Date1977-01-03
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY 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 1977-01-03 under 510(k) number K761287. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY?

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY is a medical device that received FDA 510(k) clearance on 1977-01-03. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K761287.

When did 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY receive FDA 510(k) clearance?

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY received FDA 510(k) clearance on 1977-01-03, under 510(k) number K761287.

Who is the listed applicant for 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY?

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 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY?

The FDA product code for 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY is FKP.

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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: FKP)

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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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