Home / 510(k) Clearances / K041558

510(k) K041558

STOCKERTIR PURGE CONTROL (APC) SYSTEM by Stockert Instrumente GmbH — Product Code DTW

K041558 is an FDA 510(k) premarket notification submitted by Stockert Instrumente GmbH for the device "STOCKERTIR PURGE CONTROL (APC) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2004. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. Stockert Instrumente GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2004
Date Received
June 10, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type

Other clearances by Stockert Instrumente GmbH

  • K042374 — STOCKERT SCP RHYTHM (September 23, 2004)
  • K032213 — STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (August 29, 2003)
  • K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (November 21, 2002)
  • K022280 — STOCKERT CORONARY PERFUSION CANNULAE (October 11, 2002)
  • K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA (October 9, 2002)
  • K020571 — STOCKERT CENTRIFUGAL PUMP CONSOLE (September 23, 2002)
  • K011838 — CENTRIFUGAL PUMP (February 5, 2002)
  • K011088 — SIII ALARM AMPLIFIER (May 2, 2001)

Other clearances for product code DTW

  • K150530 — Level Sensor, Level Sensor Tape (May 8, 2015)
  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (May 20, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
  • K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (May 22, 1990)
  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)
  • K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (May 30, 1986)

FDA data resources