Cleared Traditional

SMARxT Tubing and Connectors

K233702 · LivaNova USA, Inc. · Cardiovascular

Aug 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K233702 is an FDA 510(k) clearance for the SMARxT Tubing and Connectors, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by LivaNova USA, Inc. (Arvada, US). The FDA issued a Cleared decision on August 8, 2024, 265 days after receiving the submission on November 17, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4390.

Submission Details

510(k) Number	K233702 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2023
Decision Date	August 08, 2024
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF