Cleared Special

CARTO VIZIGO? 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)

K231412 · Biosense Webster, Inc. · Cardiovascular

Jul 2023

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K231412 is an FDA 510(k) clearance for the CARTO VIZIGO? 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S), a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on July 10, 2023, 55 days after receiving the submission on May 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K231412 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2023
Decision Date	July 10, 2023
Days to Decision	55 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF