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510(k) K143583

Cathivex ¿GV filter units by Merck Millipore , Ltd. — Product Code FPB

K143583 is an FDA 510(k) premarket notification submitted by Merck Millipore , Ltd. for the device "Cathivex ¿GV filter units". The FDA issued a decision of Substantially Equivalent on August 11, 2015. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Merck Millipore , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2015
Date Received
December 18, 2014
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 Merck Millipore , Ltd.

  • K133004 — VENTED MILLEX -GV, CATHIVEX -GV (March 27, 2014)

Other clearances for product code FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • 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)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources