Cleared Traditional

K143255 - Prelude SNAP Splittable Sheath Introducer

K143255 is an FDA 510(k) clearance for Prelude SNAP Splittable Sheath Introducer, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K143255

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.

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 490
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K143255.
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K150186 · Boston Scientific Corp · Jun 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · C.R. Bard, Inc. · Apr 2015
FIRSTSTIC N INTRODUCER
K141969 · Argon Medical Devices, Inc. · Dec 2014
NANOSTIM INTRODUCER KIT
K140793 · St. Jude Medical, Inc. · Dec 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · Merit Medical Systems, Inc. · Oct 2014