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510(k) K030141

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 by Cardiovention, Inc. — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2003
Date Received
January 15, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Cardiovention, Inc.

  • K032068 — CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 (August 22, 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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  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)