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FDA 510(k)

HAEMONETICS 40U RBC FILTER BAG

K-Number: K061103 · 2006-05-17

ApplicantHaemonetics Corp.
Decision Date2006-05-17
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HAEMONETICS 40U RBC FILTER BAG is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K061103. 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 HAEMONETICS 40U RBC FILTER BAG?

HAEMONETICS 40U RBC FILTER BAG is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Haemonetics Corp.. The 510(k) number is K061103.

When did HAEMONETICS 40U RBC FILTER BAG receive FDA 510(k) clearance?

HAEMONETICS 40U RBC FILTER BAG received FDA 510(k) clearance on 2006-05-17, under 510(k) number K061103.

Who is the listed applicant for HAEMONETICS 40U RBC FILTER BAG?

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

What is the FDA product code for HAEMONETICS 40U RBC FILTER BAG?

The FDA product code for HAEMONETICS 40U RBC FILTER BAG is CAK.

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Other records listing Haemonetics Corp. 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.

K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMK120586CELL SAVER ELITEK101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMK062801SMARTSUCTION SOLO DEVICEK053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)K052626SMARTSUCTION HARMONY DEVICE

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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.

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 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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