Cleared Traditional

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

K232037 · Innovative Health, LLC · Cardiovascular

Apr 2024

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K232037 is an FDA 510(k) clearance for the Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable 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 April 4, 2024, 269 days after receiving the submission on July 10, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K232037 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2023
Decision Date	April 04, 2024
Days to Decision	269 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