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FDA 510(k)

SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS

K-Number: K904221 · 1990-10-26

ApplicantBaxter Healthcare Corp
Decision Date1990-10-26
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS 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 1990-10-26 under 510(k) number K904221. 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 SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS?

SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K904221.

When did SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS receive FDA 510(k) clearance?

SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS received FDA 510(k) clearance on 1990-10-26, under 510(k) number K904221.

Who is the listed applicant for SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS?

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 SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS?

The FDA product code for SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS 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 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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