Cardiovention Powerbase Console, Model PBC-100

FDA 510(k) K021694 · Cardiovention, Inc.

Substantially Equivalent

510(k) numberK021694

Submission

Device name
Cardiovention Powerbase Console, Model PBC-100
Applicant
Cardiovention, Inc.
Santa Clara, CA, US
Received
May 22, 2002
Decision date
January 8, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4220
Specialty
Cardiovascular
Life-sustaining
Yes

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K153376Advanced Perfusion System 1DTQ · Special Terumo Cardiovascular Systems Corporation12/16/2015SE

More from Terumo Cardiovascular Systems Corporation

510(k)DeviceDecision
K032068Cardiovention Corx IOS-200 System, Model IOS-200DTR · Traditional 08/22/2003SE
K030141Modification to Cardiovention Powerbase Console, Model PCB-100DTQ · Special 02/26/2003SE
K012325Cardiovention Corx System, Model FG 0001KFM · Traditional 04/09/2002SE

Questions and answers

When was Cardiovention Powerbase Console, Model PBC-100 cleared by the FDA?

Cardiovention Powerbase Console, Model PBC-100 (K021694) received a 510(k) decision of Substantially Equivalent on January 8, 2003, 231 days after the submission was received.

What is the product code of K021694?

The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.