Cleared Traditional

K133631 - LEXIPLIANT DILATOR SHEATH SET

K133631 is an FDA 510(k) clearance for LEXIPLIANT DILATOR SHEATH SET, manufactured by Spectranetics Corporation. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K133631 · Spectranetics Corporation · Cardiovascular device
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Mar 2014
Decision
121d
Days
Class 2
Risk

K133631 is an FDA 510(k) clearance for the LEXIPLIANT DILATOR SHEATH SET. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Spectranetics Corporation (Colorado Springs, US). The FDA issued a Cleared decision on March 27, 2014 after a review of 121 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 Corporation devices

FDA 510(k) Submission Details - K133631

510(k) Number K133631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2013
Decision Date March 27, 2014
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K133631.
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
NMI COAXIAL MICROINTRODUCER SET
K123445 · Navilyst Medical, Inc. · Apr 2013