Cleared Traditional

K142819 - Shuttle SL Flexor Tuohy-Borst Side-Arm ...

K142819 is the FDA 510(k) clearance for Shuttle SL Flexor Tuohy-Borst Side-Arm ... by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K142819 · Cook Incorporated · Cardiovascular device
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Jul 2015
Decision
298d
Days
Class 2
Risk

K142819 is an FDA 510(k) clearance for the Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer 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 July 24, 2015 after a review of 298 days - an extended review cycle.

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 Cook Incorporated devices

Submission Details

510(k) Number K142819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2014
Decision Date July 24, 2015
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K142819.
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
PreludeEASE Hydrophilic Sheath Introducer
K150257 · Merit Medical Systems, Inc. · Jun 2015
Chariot Guiding Sheath
K150186 · Boston Scientific Corp · Jun 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · C.R. Bard, Inc. · Apr 2015