FDA 510(k)

MI DeTACH

K-Number: K210006 · 2021-03-04

Decision Date2021-03-04

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MI DeTACH is the device name listed in this FDA 510(k) record. The listed applicant is Biorep Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-04 under 510(k) 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. The listed applicant is Biorep Technologies, Inc.. The 510(k) number is K210006.

When did MI DeTACH receive FDA 510(k) clearance?

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

Who is the listed applicant for MI DeTACH?

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

What is the FDA product code for MI DeTACH?

The FDA product code for MI DeTACH is DXC.

Related Devices (Code: DXC)

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.