Cleared Traditional

Phoenix 2.4mm Atherectomy Plus System (K181877) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 41
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