Cleared Special

K172386 - 1.8mm X 149cm Phoenix Atherectomy System

K172386 is an FDA 510(k) clearance for 1.8mm X 149cm Phoenix Atherectomy System, manufactured by Volcano Atheromed, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 16-day FDA review.

K172386 · Volcano Atheromed, Inc. · Cardiovascular device
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Aug 2017
Decision
16d
Days
Class 2
Risk

K172386 is an FDA 510(k) clearance for the 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy S.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Volcano Atheromed, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 24, 2017 after a review of 16 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 Volcano Atheromed, Inc. devices

FDA 510(k) Submission Details - K172386

510(k) Number K172386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date August 24, 2017
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
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 76
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K172386.
Straub Endovascular System
K172315 · Straub Medical AG · Apr 2018
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Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
K172236 · Avinger, Inc. · Oct 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · Cardiovascular Systems, Inc. · Jun 2017
Pantheris Catheter (8F)
K163264 · Avinger, Inc. · Dec 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · Avinger, Inc. · Oct 2016