Cleared Special

K151145 - 2.4mm X 127 cm Phoenix Atherectomy Deflecting System

K151145 is an FDA 510(k) clearance for 2.4mm X 127 cm Phoenix Atherectomy Defl..., 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 27-day FDA review.

K151145 · Volcano Atheromed, Inc. · Cardiovascular device
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May 2015
Decision
27d
Days
Class 2
Risk

K151145 is an FDA 510(k) clearance for the 2.4mm X 127 cm Phoenix Atherectomy Deflecting System. 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 May 26, 2015 after a review of 27 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 - K151145

510(k) Number K151145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2015
Decision Date May 26, 2015
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
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 132
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K151145.
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · Cardiovascular Systems, Inc. · Oct 2015
Pantheris System
K152275 · Avinger, Inc. · Oct 2015
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
K151260 · Cardiovascular System, Inc. · Jun 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · Cardiovascular Systems, Inc. · Apr 2015
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
K143328 · Volcano Atheromed, Inc. · Dec 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014