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510(k) K032068

CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 by Cardiovention, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2003
Date Received
July 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

Other clearances by Cardiovention, Inc.

  • K030141 — MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (February 26, 2003)
  • K021694 — CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 (January 8, 2003)
  • K012325 — CARDIOVENTION CORX SYSTEM, MODEL FG 0001 (April 9, 2002)

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