Cleared Traditional

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

K231227 · Baylis Medical Company, Inc. · Cardiovascular
Dec 2023
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K231227 is an FDA 510(k) clearance for the SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on December 20, 2023, 236 days after receiving the submission on April 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K231227 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2023
Decision Date December 20, 2023
Days to Decision 236 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