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510(k) K113313

MOLECULAR ADSORBENT RECIRCULATING(MARS) by Gambro Renal Products, Inc. — Product Code FLD

K113313 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "MOLECULAR ADSORBENT RECIRCULATING(MARS)". The FDA issued a decision of Substantially Equivalent on December 14, 2012. 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
December 14, 2012
Date Received
November 9, 2011
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.

  • K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONT (March 26, 2014)
  • K131516 — PRISMAFLEX SYSTEM 7.10 (January 3, 2014)
  • K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (May 2, 2013)
  • 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

  • K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONT (March 26, 2014)
  • 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