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510(k) K842399

48 HOUR SET CHANGES by Tri-Med, Inc. — Product Code FPB

K842399 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "48 HOUR SET CHANGES". The FDA issued a decision of Substantially Equivalent on October 9, 1984. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1984
Date Received
June 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Tri-Med, Inc.

  • K040112 — TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE (March 12, 2004)
  • K030877 — TRIMED RADIAL BULLET (February 5, 2004)
  • K010545 — TBW (June 6, 2001)
  • K961863 — PARACENTESIS TRAYS (May 28, 1996)
  • K875224 — HUDSON CRANINAL BURRS (January 28, 1988)
  • K850745 — TRI-MED MODEL 112 MOISTURE TRAP (April 2, 1985)
  • K850746 — TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (April 2, 1985)
  • K850747 — TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (April 2, 1985)
  • K843681 — RESPIRATION & HEART RATE MONITOR 530 (December 4, 1984)
  • K843285 — TRI-MED 610 CAPNOSTAT GAS ANALYZER (November 13, 1984)

Other clearances for product code FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources