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FDA 510(k)

CELL SAVER ELITE

K-Number: K120586 · 2012-05-22

ApplicantHaemonetics Corp.
Decision Date2012-05-22
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CELL SAVER ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 2012-05-22 under 510(k) number K120586. 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 CELL SAVER ELITE?

CELL SAVER ELITE is a medical device that received FDA 510(k) clearance on 2012-05-22. The listed applicant is Haemonetics Corp.. The 510(k) number is K120586.

When did CELL SAVER ELITE receive FDA 510(k) clearance?

CELL SAVER ELITE received FDA 510(k) clearance on 2012-05-22, under 510(k) number K120586.

Who is the listed applicant for CELL SAVER ELITE?

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 CELL SAVER ELITE?

The FDA product code for CELL SAVER ELITE 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 SYSTEMK101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMK062801SMARTSUCTION SOLO DEVICEK061103HAEMONETICS 40U RBC FILTER BAGK053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)K052626SMARTSUCTION HARMONY DEVICE

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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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