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FDA 510(k)

AUTOTRANSFUSION APPARTUS (AUTOLOG)

K-Number: K972894 · 1998-04-27

ApplicantMedtronic Blood Management
Decision Date1998-04-27
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOTRANSFUSION APPARTUS (AUTOLOG) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Management. It received FDA 510(k) clearance on 1998-04-27 under 510(k) number K972894. 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 AUTOTRANSFUSION APPARTUS (AUTOLOG)?

AUTOTRANSFUSION APPARTUS (AUTOLOG) is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Medtronic Blood Management. The 510(k) number is K972894.

When did AUTOTRANSFUSION APPARTUS (AUTOLOG) receive FDA 510(k) clearance?

AUTOTRANSFUSION APPARTUS (AUTOLOG) received FDA 510(k) clearance on 1998-04-27, under 510(k) number K972894.

Who is the listed applicant for AUTOTRANSFUSION APPARTUS (AUTOLOG)?

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

What is the FDA product code for AUTOTRANSFUSION APPARTUS (AUTOLOG)?

The FDA product code for AUTOTRANSFUSION APPARTUS (AUTOLOG) is CAC.

Related Clinical Trials

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.

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Other records listing Medtronic Blood Management 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.

K982755MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)K981815HEPTRAC ELECTRONIC QUALITY CONTROL

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

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