Cleared Traditional

K212351 - Revolution Peripheral Atherectomy System

K212351 is an FDA 510(k) clearance for Revolution Peripheral Atherectomy System, manufactured by Rex Medical, L.P.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K212351 · Rex Medical, L.P. · Cardiovascular device
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Dec 2021
Decision
139d
Days
Class 2
Risk

K212351 is an FDA 510(k) clearance for the Revolution Peripheral Atherectomy System. 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 December 15, 2021 after a review of 139 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

FDA 510(k) Submission Details - K212351

510(k) Number K212351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2021
Decision Date December 15, 2021
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 K212351.
Auryon Atherectomy System
K221077 · Eximo Medical, Ltd. · Jun 2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K220568 · Cardiovascualr Systems, Inc. · Apr 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K220109 · Cardiovascular Systems, Inc. · Mar 2022
Pantheris System
K212047 · Avinger, Inc. · Nov 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
K210586 · Cardiovascular Systems, Inc. · Sep 2021
Rotarex Atherectomy System
K211738 · C.R. Bard, Inc. · Sep 2021