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FDA 510(k)

MI DeTACH

K-Number: K210006 · 2021-03-04

ApplicantBiorep Technologies, Inc.
Decision Date2021-03-04
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MI DeTACH is a medical device manufactured by Biorep Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-04 under approval number K210006. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MI DeTACH?

MI DeTACH is a medical device that received FDA 510(k) clearance on 2021-03-04. It is manufactured by Biorep Technologies, Inc.. The 510(k) number is K210006.

When was MI DeTACH approved by the FDA?

MI DeTACH received FDA 510(k) clearance on 2021-03-04, under approval number K210006.

What company makes MI DeTACH?

MI DeTACH is manufactured by Biorep Technologies, Inc..

What is the FDA product code for MI DeTACH?

The FDA product code for MI DeTACH is DXC.

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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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