Cleared Traditional

K143255 - Prelude SNAP Splittable Sheath Introducer

K143255 is the FDA 510(k) clearance for Prelude SNAP Splittable Sheath Introducer by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K143255 · Merit Medical Systems, Inc. · Cardiovascular device
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Apr 2015
Decision
147d
Days
Class 2
Risk

K143255 is an FDA 510(k) clearance for the Prelude SNAP Splittable Sheath Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Malvern, US). The FDA issued a Cleared decision on April 9, 2015 after a review of 147 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K143255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2014
Decision Date April 09, 2015
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 318
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K143255.
PreludeEASE Hydrophilic Sheath Introducer
K150257 · Merit Medical Systems, Inc. · Jun 2015
Chariot Guiding Sheath
K150186 · Boston Scientific Corp · Jun 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · C.R. Bard, Inc. · Apr 2015
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · Merit Medical Systems, Inc. · Oct 2014
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · Cook, Inc. · Oct 2014
MERIT SAFETY INTRODUCER NEEDLE
K140513 · Merit Medical Systems, Inc. · Jul 2014