Cleared Special

K153430 - Flexor Tuohy-Borst Side-Arm Introducers...

K153430 is the FDA 510(k) clearance for Flexor Tuohy-Borst Side-Arm Introducers... by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 103-day FDA review.

K153430 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
103d
Days
Class 2
Risk

K153430 is an FDA 510(k) clearance for the Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 7, 2016 after a review of 103 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. 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. Standard predicate reliance. 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 K153430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date March 07, 2016
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
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 K153430.
Pinpoint GT Introducer Needle
K162769 · C.R. Bard, Inc. · Nov 2016
Halo One Thin-Walled Guiding Sheath
K161183 · C.R. Bard, Inc. · Jun 2016
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 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
Flexor Radial Hydrophilic Introducer Access Set
K152044 · Cook Incorporated · Aug 2015