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FDA 510(k)

HEMA 20 MICRON TRANSFUSION BLOOD FILTER

K-Number: K812697 · 1981-10-08

ApplicantAbbott Laboratories
Decision Date1981-10-08
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEMA 20 MICRON TRANSFUSION BLOOD FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1981-10-08 under 510(k) number K812697. 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 HEMA 20 MICRON TRANSFUSION BLOOD FILTER?

HEMA 20 MICRON TRANSFUSION BLOOD FILTER is a medical device that received FDA 510(k) clearance on 1981-10-08. The listed applicant is Abbott Laboratories. The 510(k) number is K812697.

When did HEMA 20 MICRON TRANSFUSION BLOOD FILTER receive FDA 510(k) clearance?

HEMA 20 MICRON TRANSFUSION BLOOD FILTER received FDA 510(k) clearance on 1981-10-08, under 510(k) number K812697.

Who is the listed applicant for HEMA 20 MICRON TRANSFUSION BLOOD FILTER?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMA 20 MICRON TRANSFUSION BLOOD FILTER?

The FDA product code for HEMA 20 MICRON TRANSFUSION BLOOD FILTER is CAK.

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Related Devices (Code: CAK)

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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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