Cleared Special

Anivia SG1000 Pump Console

K230698 · Apmtd, Inc. · Cardiovascular

Apr 2023

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K230698 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 April 18, 2023, 36 days after receiving the submission on March 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number	K230698 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2023
Decision Date	April 18, 2023
Days to Decision	36 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF