Cleared Traditional

K190369 - M-Y Sheath

K190369 is the FDA 510(k) clearance for M-Y Sheath by Ram Medical Innovations, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K190369 · Ram Medical Innovations, Inc. · Cardiovascular device
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Apr 2019
Decision
61d
Days
Class 2
Risk

K190369 is an FDA 510(k) clearance for the M-Y Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Ram Medical Innovations, Inc. (Springfield, US). The FDA issued a Cleared decision on April 17, 2019 after a review of 61 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 Ram Medical Innovations, Inc. devices

Submission Details

510(k) Number K190369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date April 17, 2019
Days to Decision 61 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
64d faster than avg
Panel avg: 125d · This submission: 61d
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 Consultant

Lamamed Solutions, Inc.
Lloyd H Griese

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K190369.
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
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
K190688 · Baylis Medical Company, Inc. · Apr 2019
transGlideXT Expandable Introducer
K181817 · Transaortic Medical, Inc. · Mar 2019
Endophys Pressure Sensing Sheath
K190098 · Endophys Holdings, LLC · Mar 2019