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510(k) K822071

PUMP MODULES PMO LO-110-PMD 10-210 by Gambro, Inc. — Product Code DWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1982
Date Received
July 14, 1982
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 Gambro, Inc.

  • K083158 — EXALIS, SOFTWARE VERSION 1.15 (June 5, 2009)
  • K072093 — PRISMAFLEX SYSTEM, VERSION 3.20 (February 1, 2008)
  • K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (November 2, 2007)
  • K032431 — PRISMA M60/M100 SETS (September 15, 2003)
  • K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3 (September 28, 1990)
  • K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (August 30, 1990)
  • K902481 — GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER (July 27, 1990)
  • K900918 — GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (July 16, 1990)
  • K892523 — GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (May 11, 1989)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

Other clearances for product code DWB

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  • 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)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • 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)