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FDA 510(k)

HAEMONETICS CELL SAVER 4 PLUS

K-Number: K904041 · 1990-11-13

ApplicantHaemonetics Corp.
Decision Date1990-11-13
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAEMONETICS CELL SAVER 4 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K904041. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMONETICS CELL SAVER 4 PLUS?

HAEMONETICS CELL SAVER 4 PLUS is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Haemonetics Corp.. The 510(k) number is K904041.

When did HAEMONETICS CELL SAVER 4 PLUS receive FDA 510(k) clearance?

HAEMONETICS CELL SAVER 4 PLUS received FDA 510(k) clearance on 1990-11-13, under 510(k) number K904041.

Who is the listed applicant for HAEMONETICS CELL SAVER 4 PLUS?

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 CELL SAVER 4 PLUS?

The FDA product code for HAEMONETICS CELL SAVER 4 PLUS is CAC.

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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 DEVICEK061103HAEMONETICS 40U RBC FILTER BAGK053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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