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FDA 510(k)

Medtronic Commander Flex

K-Number: K191745 · 2020-05-15

ApplicantMedtronic Care Management Services
Decision Date2020-05-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medtronic Commander Flex is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Care Management Services. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K191745. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Commander Flex?

Medtronic Commander Flex is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Medtronic Care Management Services. The 510(k) number is K191745.

When did Medtronic Commander Flex receive FDA 510(k) clearance?

Medtronic Commander Flex received FDA 510(k) clearance on 2020-05-15, under 510(k) number K191745.

Who is the listed applicant for Medtronic Commander Flex?

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

What is the FDA product code for Medtronic Commander Flex?

The FDA product code for Medtronic Commander Flex is DXN.

Related Devices (Code: DXN)

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

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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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