Cleared Traditional

K183655 - VersaCross Transseptal Sheath

K183655 is the FDA 510(k) clearance for VersaCross Transseptal 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 144-day FDA review.

K183655 · Baylis Medical Company, Inc. · Cardiovascular device
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May 2019
Decision
144d
Days
Class 2
Risk

K183655 is an FDA 510(k) clearance for the VersaCross Transseptal 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 May 20, 2019 after a review of 144 days - within the typical 510(k) review window.

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 K183655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date May 20, 2019
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K183655.
Steerable Introducer
K191190 · Freudenberg Medical, LLC · Aug 2019
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
K183066 · Access Scientific, LLC · Jul 2019
FlexSeal Introducer Sheath with Hydrophilic Coating
K190628 · Freudenberg Medical Mis, Inc. · May 2019
D'Vill Introducer
K190974 · NuMED, Inc. · May 2019
BioCardia 8.5 F Avance Steerable lntroducer
K190941 · Biocardia, Inc. · May 2019
Guide Sheath
K190644 · Surmodics,Inc. · Apr 2019