MI DeTACH— 510(k) K210006

Substantially Equivalent

Biorep Technologies, Inc.

FDA 510(k) clearance K210006 for MI DeTACH, Substantially Equivalent on 2021-03-04. Applicant: Biorep Technologies, Inc..

Clearance details

Applicant: Biorep Technologies, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2021-01-04
Decision date: 2021-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.