Cleared Traditional

Anivia SG1000 Pump Console

K221491 · Apmtd, Inc. · Cardiovascular

Feb 2023

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K221491 is an FDA 510(k) clearance for the Anivia SG1000 Pump Console, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Apmtd, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 3, 2023, 256 days after receiving the submission on May 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number	K221491 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	February 03, 2023
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF