Cleared Traditional

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (K191419) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K191419 · Rex Medical, L.P. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
107d
Days
Class 2
Risk

K191419 is an FDA 510(k) clearance for the Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy G.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Rex Medical, L.P. (Conshohocken, US). The FDA issued a Cleared decision on September 12, 2019 after a review of 107 days - within the typical 510(k) review window.

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 Rex Medical, L.P. devices

Submission Details

510(k) Number K191419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2019
Decision Date September 12, 2019
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02961894 Completed Interventional Industry-sponsored

Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization

121
Patients (actual)
17
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jeffrey G Carr, MD
Sponsor Rex Medical (industry)
Started 2017-06-07 → Primary completion 2019-02-28 → Completed 2019-09-20
Primary outcome
Safety Endpoint: Number of Participants With Freedom From Major Adverse Events
Secondary outcome
Target Lesion Revascularization (TLR) Rate
View full study on ClinicalTrials.gov

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 K191419.
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
K211518 · Volcano Atheromed, Inc. · Jun 2021
Auryon Atherectomy System
K202835 · Eximo Medical, Ltd. · Dec 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K203008 · Cardiovascular Systems, Inc. · Nov 2020
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