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510(k) K982014

STOCKERT COMPACT SYSTEM by Stoeckert Instrumente — Product Code DTQ

K982014 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "STOCKERT COMPACT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
June 8, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
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)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • K962320 — S3 CARDIOPLEGIA CONTROL (January 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 DTQ

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)

FDA data resources