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FDA 510(k)

Magnetic Localization Patch Kit (AFR-00021)

K-Number: K243435 · 2024-12-05

ApplicantMedtronic, Inc.
Decision Date2024-12-05
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Magnetic Localization Patch Kit (AFR-00021) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2024-12-05 under approval number K243435. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magnetic Localization Patch Kit (AFR-00021)?

Magnetic Localization Patch Kit (AFR-00021) is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Medtronic, Inc.. The 510(k) number is K243435.

When was Magnetic Localization Patch Kit (AFR-00021) approved by the FDA?

Magnetic Localization Patch Kit (AFR-00021) received FDA 510(k) clearance on 2024-12-05, under approval number K243435.

What company makes Magnetic Localization Patch Kit (AFR-00021)?

Magnetic Localization Patch Kit (AFR-00021) is manufactured by Medtronic, Inc..

What is the FDA product code for Magnetic Localization Patch Kit (AFR-00021)?

The FDA product code for Magnetic Localization Patch Kit (AFR-00021) is DQK.

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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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