# K210006: MI DeTACH

- Pathway: 510(k) (Traditional)
- Applicant: Biorep Technologies, Inc.
- Decided: Mar 4, 2021 after 59 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973080 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010727: Flexline Clamp, Novare Surgical Systems, Inc. (2002) Summary page 5.
- K123571: Cardio Vision Mics Aortic Clamps, Cardiomedical GmbH (2013) Summary page 5.

## Indications for use
The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.

Source page: https://510kreport.com/device/K210006
Methodology: https://510kreport.com/methodology