Cleared Special

K151260 - ViperWire Advance Guide Wire

K151260 is an FDA 510(k) clearance for ViperWire Advance Guide Wire, manufactured by Cardiovascular System, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 29-day FDA review.

K151260 · Cardiovascular System, Inc. · Cardiovascular device
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Jun 2015
Decision
29d
Days
Class 2
Risk

K151260 is an FDA 510(k) clearance for the ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy .... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular System, Inc. (Saint Paul, US). The FDA issued a Cleared decision on June 10, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 Cardiovascular System, Inc. devices

FDA 510(k) Submission Details - K151260

510(k) Number K151260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date June 10, 2015
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 81
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K151260.
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · Avinger, Inc. · Mar 2016
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · Cardiovascular Systems, Inc. · Oct 2015
Pantheris System
K152275 · Avinger, Inc. · Oct 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · Cardiovascular Systems, Inc. · Apr 2015
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014