Cleared Traditional

K231227 - SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

K231227 is an FDA 510(k) clearance for SureFlex HD Steerable Sheath, manufactured by Baylis Medical Company, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K231227

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.

DYB Device Classification - Class 2, Special Controls

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 596
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