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510(k) K112225

SORIN CENTRIFUGAL PUMP 5 (CP5) by Sorin Group Deutschland GmbH — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2011
Date Received
August 3, 2011
Clearance Type
Special
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 Sorin Group Deutschland GmbH

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  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)
  • K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL W (January 20, 2011)
  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (January 6, 2011)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K093882 — SORIN C5 SYSTEM MODEL 58-00-00 (January 15, 2010)

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