Cleared Special

K153430 - Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select

K153430 is an FDA 510(k) clearance for Flexor Tuohy-Borst Side-Arm Introducers..., manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K153430

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.

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 667
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K153430.
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016
The Nanostim Introducer Kit
K160716 · St. Jude Medical, Inc. · Apr 2016
transGlide Expandable Introducer
K152194 · Transaortic Medical, Inc. · Apr 2016
Endophys Pressure Sensing Sheath Kit
K160272 · Endophys, Inc. · Mar 2016
PTFE Super Sheath Introducer 2.1
K153246 · Medcomp (Medical Components, Inc.) · Feb 2016
Fortress Introducer Sheath SYstem
K153197 · Contract Medical International, GmbH · Jan 2016
K153430 · Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
Download PDF FDA Summary Cook Incorporated