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FDA 510(k)

20 MICRON HIGH CAPACITY TRANS/FILTER

K-Number: K830057 · 1983-01-26

ApplicantTravenol Laboratories, S.A.
Decision Date1983-01-26
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

20 MICRON HIGH CAPACITY TRANS/FILTER 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 1983-01-26 under 510(k) number K830057. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20 MICRON HIGH CAPACITY TRANS/FILTER?

20 MICRON HIGH CAPACITY TRANS/FILTER is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K830057.

When did 20 MICRON HIGH CAPACITY TRANS/FILTER receive FDA 510(k) clearance?

20 MICRON HIGH CAPACITY TRANS/FILTER received FDA 510(k) clearance on 1983-01-26, under 510(k) number K830057.

Who is the listed applicant for 20 MICRON HIGH CAPACITY TRANS/FILTER?

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 20 MICRON HIGH CAPACITY TRANS/FILTER?

The FDA product code for 20 MICRON HIGH CAPACITY TRANS/FILTER is CAK.

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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: CAK)

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.

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare CorpK972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

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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