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510(k) K933523

I.V. FILTER SET by Mediziv Medical Products 1987 , Ltd. — Product Code FPB

K933523 is an FDA 510(k) premarket notification submitted by Mediziv Medical Products 1987 , Ltd. for the device "I.V. FILTER SET". The FDA issued a decision of Substantially Equivalent on May 19, 1995. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Mediziv Medical Products 1987 , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1995
Date Received
July 20, 1993
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 Mediziv Medical Products 1987 , Ltd.

  • K933898 — HUBER NEEDLE SETS (September 27, 1995)
  • K933524 — EXTENTION SET (May 23, 1995)
  • K933522 — INTRODUCER NEEDLE (SEVERAL SIZES) (February 21, 1995)

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)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources