Cleared Traditional

K183655 - VersaCross Transseptal Sheath

K183655 is an FDA 510(k) clearance for VersaCross Transseptal 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 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

FDA 510(k) Submission Details - K183655

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.

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 598
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