Cleared Traditional

K142829 - Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification (FDA 510(k) Clearance)

Also includes:
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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 700
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