Cleared Traditional

K182064 - ExpanSure Transseptal Dilation System

K182064 is an FDA 510(k) clearance for ExpanSure Transseptal Dilation System, manufactured by Baylis Medical Company, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K182064 · Baylis Medical Company, Inc. · Cardiovascular device
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Mar 2019
Decision
232d
Days
Class 2
Risk

K182064 is an FDA 510(k) clearance for the ExpanSure Transseptal Dilation System. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on March 21, 2019 after a review of 232 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 - K182064

510(k) Number K182064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date March 21, 2019
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 79
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K182064.
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Dilator Sets
K183036 · Cook Incorporated · Dec 2018
MC3 Vascular Access Kit 21030
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Coaxial Dilator Set (Micro-Introducer)
K172487 · Galt Medical Corp. · Oct 2017