Cleared Traditional

K181877 - Phoenix 2.4mm Atherectomy Plus System

K181877 is an FDA 510(k) clearance for Phoenix 2.4mm Atherectomy Plus System, manufactured by Volcano Atheromed, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K181877 · Volcano Atheromed, Inc. · Cardiovascular device
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Dec 2018
Decision
157d
Days
Class 2
Risk

K181877 is an FDA 510(k) clearance for the Phoenix 2.4mm Atherectomy Plus 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 December 17, 2018 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Volcano Atheromed, Inc. devices

FDA 510(k) Submission Details - K181877

510(k) Number K181877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2018
Decision Date December 17, 2018
Days to Decision 157 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K181877.
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
K190634 · Cardiovascular Systems, Inc. · Jul 2019
Pantheris SV
K182341 · Avinger, Inc. · Apr 2019
Phoenix Atherectomy System
K182972 · Volcano Atheromed, Inc. · Dec 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · Cardiovascular Systems, Inc. · Dec 2018
B-Laser Atherectomy System
K181642 · Eximo Medical, Ltd. · Oct 2018
Pantheris System
K173862 · Avinger, Inc. · May 2018