Cleared Special

K152116 - 5.5 F Worley Advanced LVI Lateral Vein ...

K152116 is the FDA 510(k) clearance for 5.5 F Worley Advanced LVI Lateral Vein ... by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K152116 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
28d
Days
Class 2
Risk

K152116 is an FDA 510(k) clearance for the 5.5 F Worley Advanced LVI Lateral Vein 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 August 27, 2015 after a review of 28 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

Submission Details

510(k) Number K152116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2015
Decision Date August 27, 2015
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K152116.
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · Cook Incorporated · Mar 2016
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · Merit Medical Systems, Inc. · Oct 2015
Flexor Radial Hydrophilic Introducer Access Set
K152044 · Cook Incorporated · Aug 2015
Confida Adaptive Sheath
K152054 · Medtronic, Inc. · Aug 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
K142829 · Cook Incorporated · Jul 2015