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510(k) K091008

STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 by Sorin Group Deutschland GmbH — Product Code DWA

K091008 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55". The FDA issued a decision of Substantially Equivalent on July 15, 2009. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2009
Date Received
April 9, 2009
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

  • K170460 — Sorin Connect (June 8, 2017)
  • K131553 — XTRA (March 21, 2014)
  • K140012 — SORIN FLEXTHERM (January 31, 2014)
  • K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM (July 23, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • 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)

Other clearances for product code DWA

  • K232788 — INSPIRA ART100 (May 24, 2024)
  • K230698 — Anivia SG1000 Pump Console (April 18, 2023)
  • K221491 — Anivia SG1000 Pump Console (February 3, 2023)
  • K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pre (April 13, 2020)
  • K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, C (March 6, 2020)
  • K191557 — CentriMag Acute Circulatory Support System (July 10, 2019)
  • K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (July 24, 2013)
  • K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (July 18, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)

FDA data resources