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FDA 510(k)

MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)

K-Number: K982755 · 1998-08-20

ApplicantMedtronic Blood Management
Decision Date1998-08-20
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF AUTOTRANSFUSION APPARATUS (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 1998-08-20 under 510(k) number K982755. 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 MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)?

MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Medtronic Blood Management. The 510(k) number is K982755.

When did MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) receive FDA 510(k) clearance?

MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) received FDA 510(k) clearance on 1998-08-20, under 510(k) number K982755.

Who is the listed applicant for MODIFICATION OF AUTOTRANSFUSION APPARATUS (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 MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)?

The FDA product code for MODIFICATION OF AUTOTRANSFUSION APPARATUS (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.

K981815HEPTRAC ELECTRONIC QUALITY CONTROLK972894AUTOTRANSFUSION APPARTUS (AUTOLOG)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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