Cleared Traditional

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

K212165 · Innovative Health, LLC · Cardiovascular

Mar 2022

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K212165 is an FDA 510(k) clearance for the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath, a Reprocessed Catheter Introducer (Class II — Special Controls, product code PNE), submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on March 10, 2022, 241 days after receiving the submission on July 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K212165 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2021
Decision Date	March 10, 2022
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PNE — Reprocessed Catheter Introducer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1340
Definition	Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System