Cardiovention Corx IOS-200 System, Model IOS-200

FDA 510(k) K032068 · Cardiovention, Inc.

Substantially Equivalent

510(k) numberK032068

Submission

Device name
Cardiovention Corx IOS-200 System, Model IOS-200
Applicant
Cardiovention, Inc.
Santa Clara, CA, US
Received
July 3, 2003
Decision date
August 22, 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
DTR – Heat-Exchanger, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4240
Specialty
Cardiovascular
Life-sustaining
Yes

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More from Quest Medical, Inc.

510(k)DeviceDecision
K030141Modification to Cardiovention Powerbase Console, Model PCB-100DTQ · Special 02/26/2003SE
K021694Cardiovention Powerbase Console, Model PBC-100DTQ · Traditional 01/08/2003SE
K012325Cardiovention Corx System, Model FG 0001KFM · Traditional 04/09/2002SE

Questions and answers

When was Cardiovention Corx IOS-200 System, Model IOS-200 cleared by the FDA?

Cardiovention Corx IOS-200 System, Model IOS-200 (K032068) received a 510(k) decision of Substantially Equivalent on August 22, 2003, 50 days after the submission was received.

What is the product code of K032068?

The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.