Skip to content

Rotablator and ROTAPRO Rotational Atherectomy System

by Boston Scientific

PMA P900056510(k) K220962

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

2 ongoing

Recall on shared PMA P900056; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220962 Date6 Sep 2022ClearedStatusActive
United StatesFDA PMA PMA NumberP900056 Date28 May 1993ApprovedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0915-2022 FDA Class II initiated 8 Mar 2022 on shared PMA P900056
    • Ongoing Z-0916-2022 FDA Class II initiated 8 Mar 2022 on shared PMA P900056

    Pouch seals may be open, compromising sterility.

  • 2 recalls, same reason

    • Terminated Z-0212-2016 FDA Class I initiated 9 Oct 2015 on shared PMA P900056
    • Terminated Z-0211-2016 FDA Class I initiated 9 Oct 2015 on shared PMA P900056

    Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Trade name
Rotablator(R)
Generic name
CATHETER, CORONARY, ATHERECTOMY
FDA applicant
Boston Scientific Corporation
PMA number
510(k) Number
FDA product code
MCW
Device class
Class II
Regulation
21 CFR Part 870.4875
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rotablator and ROTAPRO Rotational Atherectomy System is a coronary atherectomy catheter designed for use in cardiovascular procedures. This device is classified as a Class 2 medical device under regulation number 870.4875.

This system is manufactured by Boston Scientific Corporation and is subject to both FDA 510(k) and PMA authorizations. It is intended for use by medical professionals in clinical settings for the removal of plaque from coronary arteries.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Rotablator and ROTAPRO system?

    The system functions as a coronary atherectomy catheter, which is a specialized medical device used to remove plaque from the coronary arteries.

  • Is this device regulated by the FDA?

    Yes, the device is regulated by the FDA and holds both 510(k) and PMA authorizations, indicating it has undergone the necessary regulatory review processes.

  • Who is the manufacturer of this atherectomy system?

    The Rotablator and ROTAPRO Rotational Atherectomy System is manufactured by Boston Scientific Corporation, based in Maple Grove, Minnesota.