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510(k) K011838

CENTRIFUGAL PUMP by Stockert Instrumente GmbH — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2002
Date Received
June 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

Other clearances by Stockert Instrumente GmbH

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  • K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (November 21, 2002)
  • K022280 — STOCKERT CORONARY PERFUSION CANNULAE (October 11, 2002)
  • K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA (October 9, 2002)
  • K020571 — STOCKERT CENTRIFUGAL PUMP CONSOLE (September 23, 2002)
  • K011088 — SIII ALARM AMPLIFIER (May 2, 2001)

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