Skip to content

Medtronic Performer CpB, Model R51, Pcpb

by Rand S.R.L.

510(k) K052555

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052555 Date15 Mar 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1090-2007 FDA Unclassified (pre-2012) initiated 4 Jun 2007

    Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medtronic Performer Tm Cpb, Model R51, Pcpb
510(k) Number
FDA Product Code
DTQ
Device Class
Class II
Regulation
21 CFR Part 870.4220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Medtronic Performer CpB, Model R51, Pcpb is a Console, Heart-Lung Machine, Cardiopulmonary Bypass device. It is designed to provide total circulatory support of the cardiopulmonary system using a centrifugal pump. The device is used during cardiopulmonary bypass procedures.

The Medtronic Performer CpB, Model R51, Pcpb is supplied by Rand S.R.L. and has FDA 510K authorization. The device has a product code of DTQ and is classified under regulation number 870.4220. It is used in cardiovascular medical specialty and has a device class of 2.

Other devices from Rand S.R.L.

Questions

AI-generated answers, 27 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 Medtronic Performer CpB used for?

    The Medtronic Performer CpB is used to provide total circulatory support of the cardiopulmonary system during cardiopulmonary bypass procedures.

  • Is the Medtronic Performer CpB supplied sterile?

    The description does not specify if the device is supplied sterile, but it is designed for use in cardiovascular medical specialties.

  • What is the regulatory classification of the Medtronic Performer CpB?

    The Medtronic Performer CpB has a device class of 2 and is classified under regulation number 870.4220.