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FDA 510(k)

FENWAL 40 MICRON TRANSFUSION FILTER

K-Number: K972159 · 1997-07-23

ApplicantBaxter Healthcare Corp
Decision Date1997-07-23
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FENWAL 40 MICRON TRANSFUSION FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K972159. 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 FENWAL 40 MICRON TRANSFUSION FILTER?

FENWAL 40 MICRON TRANSFUSION FILTER is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K972159.

When did FENWAL 40 MICRON TRANSFUSION FILTER receive FDA 510(k) clearance?

FENWAL 40 MICRON TRANSFUSION FILTER received FDA 510(k) clearance on 1997-07-23, under 510(k) number K972159.

Who is the listed applicant for FENWAL 40 MICRON TRANSFUSION FILTER?

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

What is the FDA product code for FENWAL 40 MICRON TRANSFUSION FILTER?

The FDA product code for FENWAL 40 MICRON TRANSFUSION FILTER is CAK.

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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 CorpK970225ALPHA MICRON 20/40 MICROAGGREGATE FILTERAlpha Therapeutic 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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