Cleared Traditional

K190628 - FlexSeal Introducer Sheath with Hydrophilic Coating (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190628 · Freudenberg Medical Mis, Inc. · Cardiovascular device
May 2019
Decision
79d
Days
Class 2
Risk

K190628 is an FDA 510(k) clearance for the FlexSeal Introducer Sheath with Hydrophilic Coating. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Freudenberg Medical Mis, Inc. (Jeffersonville, US). The FDA issued a Cleared decision on May 30, 2019 after a review of 79 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.

Submission Details

510(k) Number K190628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2019
Decision Date May 30, 2019
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 44
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K190628.
Multiflex Steerable Sheath 17.5F
K260626 · Vizaramed, Inc. · Mar 2026
AuST CSP Introducer
K260163 · CenterPoint Systems, LLC · Feb 2026
Peel-Away Introducer Sheath
K254236 · VascuTech Medical, LLC · Feb 2026
Genie MAX Large Bore Introducer Sheath
K253652 · Cultiv8 1, LLC · Jan 2026
Intri26 Introducer Sheath
K252508 · Inari Medical, Inc. · Dec 2025
V•Stick™ Vascular Access Set
K253741 · Argon Medical Devices, Inc. · Dec 2025