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510(k) K853406

GAMBRO LUNDIA PRO 3 & 5 DIALYZER by Gambro, Inc. — Product Code FJG

K853406 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO LUNDIA PRO 3 & 5 DIALYZER". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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 FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (August 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (August 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)
  • K811439 — EXP 200 PARALLEL PLATE DIALYZER (June 12, 1981)

FDA data resources