Cleared Traditional

K210862 - Hemafuse System (FDA 510(k) Clearance)

K210862 · Sisu Global Health · Cardiovascular device

Jul 2021

Decision

128d

Days

Class 2

Risk

K210862 is an FDA 510(k) clearance for the Hemafuse System. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Sisu Global Health (Baltimore, US). The FDA issued a Cleared decision on July 29, 2021, 128 days after receiving the submission on March 23, 2021.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K210862 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 23, 2021
Decision Date	July 29, 2021
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement