Cleared Traditional

K210006 - MI DeTACH (FDA 510(k) Clearance)

K210006 · Biorep Technologies, Inc. · Cardiovascular device

Mar 2021

Decision

59d

Days

Class 2

Risk

K210006 is an FDA 510(k) clearance for the MI DeTACH. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).

Submitted by Biorep Technologies, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on March 4, 2021, 59 days after receiving the submission on January 4, 2021.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K210006 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 04, 2021
Decision Date	March 04, 2021
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF