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510(k) K133807

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT by Gambro Renal Products, Inc. — Product Code FLD

K133807 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code FLD (Apparatus, Hemoperfusion, Sorbent), a Class II device regulated under 21 CFR 876.5870. Gambro Renal Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2014
Date Received
December 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Hemoperfusion, Sorbent
Device Class
Class II
Regulation Number
876.5870
Review Panel
GU
Submission Type

Other clearances by Gambro Renal Products, Inc.

  • K131516 — PRISMAFLEX SYSTEM 7.10 (January 3, 2014)
  • K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (May 2, 2013)
  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY (May 25, 2012)
  • K110823 — PRISMAFLEX (June 17, 2011)
  • K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM (May 20, 2011)
  • K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW (December 21, 2010)
  • K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (November 3, 2010)
  • K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (July 29, 2010)
  • K080519 — PRISMAFLEX M150 SET (June 13, 2008)

Other clearances for product code FLD

  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (May 27, 2005)
  • K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (September 10, 1999)
  • K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000- (August 13, 1999)
  • K971015 — AHCS HEMOPERFUSION SYSTEM (October 22, 1997)
  • K953751 — BIOLOGIC-DT SYSTEM (February 15, 1996)
  • K885017 — HEMOSORBA CH-500, CH-350 AND CH-180 (March 17, 1989)
  • K873643 — GAMBRO ADSORBA 150C (December 29, 1987)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K831029 — HEMOPERFUSION SYSTEM TP-400 (August 26, 1983)

FDA data resources