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510(k) K992635

INTERFACE MODULE IDDD by Stoeckert Instrumente — Product Code KRI

K992635 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "INTERFACE MODULE IDDD". The FDA issued a decision of Substantially Equivalent on December 20, 1999. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1999
Date Received
August 6, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
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)
  • 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)
  • 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 KRI

  • K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (May 3, 2002)
  • K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (November 23, 1999)
  • K934782 — AMMEX TUBING ORGANIZER (November 18, 1993)
  • K926233 — CARDIO2 CYCLE (June 4, 1993)
  • K922404 — TUBE GRIP (November 23, 1992)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

FDA data resources