Cleared Traditional

K191190 - Steerable Introducer

K191190 is an FDA 510(k) clearance for Steerable Introducer, manufactured by Freudenberg Medical, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K191190 · Freudenberg Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
90d
Days
Class 2
Risk

K191190 is an FDA 510(k) clearance for the Steerable Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Freudenberg Medical, LLC (Jeffersonville, US). The FDA issued a Cleared decision on August 1, 2019 after a review of 90 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 Freudenberg Medical, LLC devices

FDA 510(k) Submission Details - K191190

510(k) Number K191190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2019
Decision Date August 01, 2019
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 432
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K191190.
AcQRef Introducer Sheath
K192106 · Acutus Medical, Inc. · Sep 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · Boston Scientific Corporation · Aug 2019
Epicardial Access System
K191546 · Baylis Medical Company, Inc. · 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
VersaCross Transseptal Sheath
K183655 · Baylis Medical Company, Inc. · May 2019