Home / 510(k) Clearances / K101046

510(k) K101046

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM by Sorin Group Deutschland GmbH — Product Code DTX

K101046 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 2010. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2010
Date Received
April 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
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)
  • K093882 — SORIN C5 SYSTEM MODEL 58-00-00 (January 15, 2010)

Other clearances for product code DTX

  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)
  • K181942 — Quantum Ventilation Module (October 18, 2018)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K863902 — MODIFIED SARNS MEMBRANE OXYGENATOR (December 11, 1986)
  • K822820 — GAS-FLOW METER GFL 10 (October 18, 1982)
  • K792348 — STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (December 5, 1979)
  • K790546 — FLOWMETER, OPTIFLO GAS (May 11, 1979)

FDA data resources