Home / 510(k) Clearances / K962320

510(k) K962320

S3 CARDIOPLEGIA CONTROL by Stoeckert Instrumente — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

Other clearances by Stoeckert Instrumente

  • K002273 — STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE (January 29, 2001)
  • K001961 — STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE (January 25, 2001)
  • K002118 — STOCKERT COMPACT SYSTEM VERSION 2.0 (August 9, 2000)
  • K992635 — INTERFACE MODULE IDDD (December 20, 1999)
  • K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (November 23, 1999)
  • K982014 — STOCKERT COMPACT SYSTEM (September 4, 1998)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)

Other clearances for product code DTR

  • K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (March 12, 2026)
  • K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery (July 8, 2025)
  • K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGU (May 30, 2025)
  • K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther (February 23, 2024)
  • K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (April 13, 2023)
  • K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat (May 6, 2022)
  • K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc (January 10, 2022)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)