Cleared Traditional

K220962 - ROTAPRO Rotational Atherectomy System

K220962 is the FDA 510(k) clearance for ROTAPRO Rotational Atherectomy System by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 52
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
K220116 · Eximo Medical, Ltd. · Sep 2022
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