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Modification to Cardiovention Powerbase Console, Model PCB-100

by Cardiovention, Inc.

510(k) K030141

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

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 · Special NumberK030141 Date26 Feb 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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, 6 Oct 2026

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

The Modification to Cardiovention Powerbase Console, Model PCB-100 is a cardiopulmonary bypass flow control device. It is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support.

The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. It is substantially equivalent in intended use and/or method of operation to the CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325]. The device has received FDA 510(k) clearance under K030141.

Other devices from Cardiovention, Inc.

Questions

AI-generated answers, 6 Oct 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 Modification to Cardiovention Powerbase Console, Model PCB-100 used for?

    It is a cardiopulmonary bypass flow control device intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support, with a maximum blood flow rate of six liters per minute and a duration of up to six hours.

  • How is the Modification to Cardiovention Powerbase Console, Model PCB-100 supplied?

    The device data does not specify supply details such as packaging, sterility, or whether it is single-use or reusable; only its intended use, model number, and FDA 510(k) clearance are provided.

  • What regulatory clearance does the Modification to Cardiovention Powerbase Console, Model PCB-100 have?

    The device has received FDA 510(k) clearance under K030141 and is substantially equivalent to the CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325].