FDA 510(k)

CYCLER SETS MOD. #5C4143, 5C4144, 5C4145

K-Number: K791899 · 1979-11-13

Decision Date1979-11-13

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 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 1979-11-13 under 510(k) number K791899. 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 CYCLER SETS MOD. #5C4143, 5C4144, 5C4145?

CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K791899.

When did CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 receive FDA 510(k) clearance?

CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 received FDA 510(k) clearance on 1979-11-13, under 510(k) number K791899.

Who is the listed applicant for CYCLER SETS MOD. #5C4143, 5C4144, 5C4145?

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 CYCLER SETS MOD. #5C4143, 5C4144, 5C4145?

The FDA product code for CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 is KDJ.

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Other records listing Travenol Laboratories, S.A. as applicant

K874181BAXTER BEDSIDE SYSTEM K873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE K873873RESUBMITTED MICRON TRANSFUSION FILTER K873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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.