FDA 510(k)

EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153

K-Number: K851207 · 1985-04-08

Decision Date1985-04-08

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 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 1985-04-08 under 510(k) number K851207. 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 EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153?

EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K851207.

When did EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 receive FDA 510(k) clearance?

EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 received FDA 510(k) clearance on 1985-04-08, under 510(k) number K851207.

Who is the listed applicant for EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153?

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 EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153?

The FDA product code for EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 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.