Cleared Traditional

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

K170997 · Biosense Webster, Inc. · Cardiovascular
Jul 2017
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K170997 is an FDA 510(k) clearance for the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 25, 2017, 113 days after receiving the submission on April 3, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K170997 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2017
Decision Date July 25, 2017
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340