Cleared Traditional

K231227 - SureFlex HD Steerable Sheath

K231227 is the FDA 510(k) clearance for SureFlex HD Steerable Sheath by Baylis Medical Company, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

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

K231227 is an FDA 510(k) clearance for the SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on December 20, 2023 after a review of 236 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baylis Medical Company, Inc. devices

Submission Details

510(k) Number K231227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K231227.
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
K233708 · Synaptic Medical Corporation · Feb 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · AtriCure, Inc. · Feb 2024
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S )
K240004 · Circa Scientific, Inc. · Jan 2024
FlexCath Cross Transseptal Solution
K233691 · Acutus Medical, Inc. · Dec 2023
Intri24 Introducer Sheath (52-101)
K233646 · Inari Medical, Inc. · Dec 2023
10F Sheath and Dilator Set
K233432 · Argon Medical Devices, Inc. · Dec 2023