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FDA 510(k)

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

K-Number: K131964 · 2013-07-24

ApplicantMedtronic, Inc.
Decision Date2013-07-24
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2013-07-24 under 510(k) number K131964. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE?

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE is a medical device that received FDA 510(k) clearance on 2013-07-24. The listed applicant is Medtronic, Inc.. The 510(k) number is K131964.

When did BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE receive FDA 510(k) clearance?

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE received FDA 510(k) clearance on 2013-07-24, under 510(k) number K131964.

Who is the listed applicant for BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE?

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

What is the FDA product code for BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE?

The FDA product code for BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE is DWA.

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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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