Cleared Special

K150360 - TightRail Rotating Dilator Sheath

K150360 is an FDA 510(k) clearance for TightRail Rotating Dilator Sheath, manufactured by Spectranetics, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Special 510(k) pathway after a 20-day FDA review.

K150360 · Spectranetics, Inc. · Cardiovascular device
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Mar 2015
Decision
20d
Days
Class 2
Risk

K150360 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath, TightRail Mini Rotating 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 March 4, 2015 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spectranetics, Inc. devices

FDA 510(k) Submission Details - K150360

510(k) Number K150360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2015
Decision Date March 04, 2015
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K150360.
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LEXICONTURE MECHANICAL DILATOR SHEATH SET
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NMI COAXIAL MICROINTRODUCER SET
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PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013