Cleared Traditional

K220962 - ROTAPRO Rotational Atherectomy System

K220962 is an FDA 510(k) clearance for ROTAPRO Rotational Atherectomy System, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K220962 · Boston Scientific Corporation · Cardiovascular device
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Sep 2022
Decision
158d
Days
Class 2
Risk

K220962 is an FDA 510(k) clearance for the ROTAPRO Rotational Atherectomy System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on September 6, 2022 after a review of 158 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K220962

510(k) Number K220962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2022
Decision Date September 06, 2022
Days to Decision 158 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
33d slower than avg
Panel avg: 125d · This submission: 158d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K220962.
Pantheris LV Atherectomy Catheter
K230005 · Avinger, Inc. · Jun 2023
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K222837 · Spectranetics, Inc. · Dec 2022
Auryon Atherectomy Catheters
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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