Cleared Traditional

K140047 - LEXICONTURE MECHANICAL DILATOR SHEATH SET

K140047 is an FDA 510(k) clearance for LEXICONTURE MECHANICAL DILATOR SHEATH SET, manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K140047 · Spectranetics Corp. · Cardiovascular device
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Apr 2014
Decision
90d
Days
Class 2
Risk

K140047 is an FDA 510(k) clearance for the LEXICONTURE MECHANICAL DILATOR SHEATH SET. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Spectranetics Corp. (Colorado Springs, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 90 days - within the typical 510(k) review window.

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: 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 Spectranetics Corp. devices

FDA 510(k) Submission Details - K140047

510(k) Number K140047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2014
Decision Date April 09, 2014
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 87
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K140047.
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · Spectranetics, Inc. · Sep 2014
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
K141148 · Cook Vascular, Inc. · Jul 2014
TIGHTRAIL MINI
K141131 · Spectranetics, Inc. · May 2014
LEXIPLIANT DILATOR SHEATH SET
K133631 · Spectranetics Corporation · Mar 2014
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013
LAWMAX DILATOR
K123842 · Lifetech Scientific (Shenzhen) Co., Ltd. · Jun 2013