Cleared Traditional

K142301 - Evolution Mechanical Dilator Sheath Set

K142301 is an FDA 510(k) clearance for Evolution Mechanical Dilator Sheath Set, manufactured by Cook Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K142301 · Cook Vascular, Inc. · Cardiovascular device
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Nov 2014
Decision
86d
Days
Class 2
Risk

K142301 is an FDA 510(k) clearance for the Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator.... Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Vandergrift, US). The FDA issued a Cleared decision on November 12, 2014 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Vascular, Inc. devices

FDA 510(k) Submission Details - K142301

510(k) Number K142301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date November 12, 2014
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 59
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K142301.
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K162181 · Cardiacassist, Inc. · Jan 2017
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
LEXICONTURE MECHANICAL DILATOR SHEATH SET
K140047 · Spectranetics Corp. · Apr 2014
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013