Cleared Special

K152044 - Flexor Radial Hydrophilic Introducer Ac...

K152044 is the FDA 510(k) clearance for Flexor Radial Hydrophilic Introducer Ac... by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 22-day FDA review.

K152044 · Cook Incorporated · Cardiovascular device
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Aug 2015
Decision
22d
Days
Class 2
Risk

K152044 is an FDA 510(k) clearance for the Flexor Radial Hydrophilic Introducer Access Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 14, 2015 after a review of 22 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 Cook Incorporated devices

Submission Details

510(k) Number K152044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2015
Decision Date August 14, 2015
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 K152044.
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
5.5 F Worley Advanced LVI Lateral Vein Introducer
K152116 · Merit Medical Systems, Inc. · Aug 2015
Confida Adaptive Sheath
K152054 · Medtronic, Inc. · Aug 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
K142829 · Cook Incorporated · Jul 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
K142819 · Cook Incorporated · Jul 2015