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510(k) K971520

S3 CYCLIC RPM CONTROL by Stoeckert Instrumente — Product Code DWB

K971520 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "S3 CYCLIC RPM CONTROL". The FDA issued a decision of Substantially Equivalent on September 10, 1997. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1997
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class
Class II
Regulation Number
870.4370
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)
  • 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 DWB

  • K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll (November 17, 2016)
  • K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER P (September 27, 2013)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM (April 27, 1998)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K960974 — COBE CENTURY PERFUSION PUMP (July 14, 1997)
  • K953901 — SARNS 800 ROLLER PUMP (April 19, 1996)
  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)
  • K890904 — MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (April 12, 1989)

FDA data resources