Cleared Traditional

K142829 - Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification

Also marketed or referenced as:
Flexor Check-Flo Introducer, Ansel Modification Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design Flexor Up and Over Balkin Contralateral Introducer Flexor Check-Flo Introducer, Raabe Modification Flexor Check-Flo Performer Introducer

K142829 is an FDA 510(k) clearance for Flexor Tuohy-Borst Side-Arm Introducer, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K142829 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
301d
Days
Class 2
Risk

K142829 is an FDA 510(k) clearance for the Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification. 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 28, 2015 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K142829

510(k) Number K142829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date July 28, 2015
Days to Decision 301 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
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 490
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K142829.
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
Confida Adaptive Sheath
K152054 · Medtronic, Inc. · Aug 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
K142819 · Cook Incorporated · Jul 2015
PreludeEASE Hydrophilic Sheath Introducer
K150257 · Merit Medical Systems, Inc. · Jun 2015
Chariot Guiding Sheath
K150186 · Boston Scientific Corp · Jun 2015