Cleared Special

K122190 - PRELUDE 7F SHORT SHEATH INTRODUCER

K122190 is an FDA 510(k) clearance for PRELUDE 7F SHORT SHEATH INTRODUCER, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 24-day FDA review.

K122190 · Merit Medical Systems, Inc. · Cardiovascular device
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Aug 2012
Decision
24d
Days
Class 2
Risk

K122190 is an FDA 510(k) clearance for the PRELUDE 7F SHORT SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Angleton, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K122190

510(k) Number K122190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2012
Decision Date August 17, 2012
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 510
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122190.
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
K121504 · Togo Medikit Co., Ltd. · Sep 2012
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · Oscor, Inc. · Aug 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · Thomas Medical Products, Inc. · Aug 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · Oscor, Inc. · Jun 2012
GORE DRYSEAL SHEATH
K120428 · W.L. Gore & Associates, Inc. · Apr 2012