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FDA 510(k)

BIO-CONSOLE, MODEL 560

K-Number: K051303 · 2005-06-10

ApplicantMedtronic Perfusion Systems
Decision Date2005-06-10
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-CONSOLE, MODEL 560 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2005-06-10 under 510(k) number K051303. 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, MODEL 560?

BIO-CONSOLE, MODEL 560 is a medical device that received FDA 510(k) clearance on 2005-06-10. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K051303.

When did BIO-CONSOLE, MODEL 560 receive FDA 510(k) clearance?

BIO-CONSOLE, MODEL 560 received FDA 510(k) clearance on 2005-06-10, under 510(k) number K051303.

Who is the listed applicant for BIO-CONSOLE, MODEL 560?

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

What is the FDA product code for BIO-CONSOLE, MODEL 560?

The FDA product code for BIO-CONSOLE, MODEL 560 is DWA.

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Related Devices (Code: DWA)

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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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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