Cleared Traditional

K191546 - Epicardial Access System

K191546 is the FDA 510(k) clearance for Epicardial Access System by Baylis Medical Company, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K191546 · Baylis Medical Company, Inc. · Cardiovascular device
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Aug 2019
Decision
51d
Days
Class 2
Risk

K191546 is an FDA 510(k) clearance for the Epicardial Access System. 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 August 2, 2019 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baylis Medical Company, Inc. devices

Submission Details

510(k) Number K191546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2019
Decision Date August 02, 2019
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K191546.
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The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
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