Cleared Traditional

K142546 - TightRail Rotating Dilator Sheath/Tight...

K142546 is an FDA 510(k) clearance for TightRail Rotating Dilator Sheath/Tight..., manufactured by Spectranetics, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K142546 · Spectranetics, Inc. · Cardiovascular device
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Sep 2014
Decision
15d
Days
Class 2
Risk

K142546 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on September 25, 2014 after a review of 15 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 Spectranetics, Inc. devices

FDA 510(k) Submission Details - K142546

510(k) Number K142546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date September 25, 2014
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 51
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K142546.
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