Autotransfusion Appartus (Autolog)

FDA 510(k) K972894 · Medtronic Blood Management

Substantially Equivalent

510(k) numberK972894

Submission

Device name
Autotransfusion Appartus (Autolog)
Applicant
Medtronic Blood Management
Parker, CO, US
Received
August 5, 1997
Decision date
April 27, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAC – Apparatus, Autotransfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5830
Specialty
Anesthesiology
Life-sustaining
Yes

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K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special Fresenius Kabi AG02/11/2021SE

More from Fresenius Kabi AG

510(k)DeviceDecision
K982755Modification of Autotransfusion Apparatus (Autolog)CAC · Traditional 08/20/1998SE
K981815Heptrac Electronic Quality ControlJPA · Traditional 07/30/1998SE

Questions and answers

When was Autotransfusion Appartus (Autolog) cleared by the FDA?

Autotransfusion Appartus (Autolog) (K972894) received a 510(k) decision of Substantially Equivalent on April 27, 1998, 265 days after the submission was received.

What is the product code of K972894?

The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.