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510(k) K831350

IVFLO-HP & IVFIL-HP FILTER by Tri-Med, Inc. — Product Code FPB

K831350 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "IVFLO-HP & IVFIL-HP FILTER". The FDA issued a decision of Substantially Equivalent on Aug 12, 1983. 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
Aug 12, 1983
Date Received
Apr 25, 1983
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 (Mar 12, 2004)
  • K030877 — TRIMED RADIAL BULLET (Feb 5, 2004)
  • K010545 — TBW (Jun 6, 2001)
  • K961863 — PARACENTESIS TRAYS (May 28, 1996)
  • K875224 — HUDSON CRANINAL BURRS (Jan 28, 1988)
  • K850747 — TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (Apr 2, 1985)
  • K850745 — TRI-MED MODEL 112 MOISTURE TRAP (Apr 2, 1985)
  • K850746 — TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (Apr 2, 1985)
  • K843681 — RESPIRATION & HEART RATE MONITOR 530 (Dec 4, 1984)
  • K843285 — TRI-MED 610 CAPNOSTAT GAS ANALYZER (Nov 13, 1984)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (Aug 31, 2026)
  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (Aug 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (Dec 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (Aug 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (Dec 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (Feb 11, 1998)
  • K964283 — AUTOPRIME (Jan 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (Jan 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)

FDA data resources