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Mi Detach

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210006

by Biorep Technologies, Inc.

Identifiers

510(k) Number
K210006 FDA 510(k)
FDA Product Code
DXC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mi Detach is an aortic cross-clamp system designed to enable precise and controlled occlusion during both open and minimally invasive surgical procedures. The system features a detachable clamp head and a dedicated delivery mechanism that allows surgeons to position and secure the clamp before removing the handle to maintain a clear operative field.

This device is classified as a cardiovascular device under product code DXC. It has received FDA 510(k) clearance through the traditional pathway under K210006.

Frequently asked questions

What is the primary function of the Mi DeTACH system?

The Mi DeTACH is an aortic cross-clamp system engineered to provide precise and controlled occlusion of the aorta. It is designed for use during both open and minimally invasive surgical procedures to assist surgeons in managing blood flow.

How does the Mi DeTACH design improve the surgical field?

The system features a detachable clamp head and a dedicated delivery mechanism. This allows the surgeon to position and secure the clamp precisely before removing the handle, which helps maintain a clear and unobstructed operative field throughout the procedure.

What is the regulatory status of the Mi DeTACH?

The Mi DeTACH has received FDA 510(k) clearance through the traditional pathway under K210006. It is classified as a cardiovascular device under product code DXC.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DeTACH - Biorep Technologies, K210006 - MI DeTACH | FDA 510 (k) | Biorep Technologies, Inc., Medical Device Contract Manufacturing & CDMO Services | Biorep Technologies

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biorep Technologies, Inc.

Sources (1)

  • FDA 510(k) K210006 24 fields · synced Sep 27, 2026