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510(k) K012325

CARDIOVENTION CORX SYSTEM, MODEL FG 0001 by Cardiovention, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2002
Date Received
July 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Cardiovention, Inc.

  • K032068 — CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 (August 22, 2003)
  • K030141 — MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (February 26, 2003)
  • K021694 — CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 (January 8, 2003)

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