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510(k) K021293

ARTERIA BLOOD FILTER by Arteria Medical Science, Inc. — Product Code FPB

K021293 is an FDA 510(k) premarket notification submitted by Arteria Medical Science, Inc. for the device "ARTERIA BLOOD FILTER". The FDA issued a decision of Substantially Equivalent on August 22, 2002. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Arteria Medical Science, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2002
Date Received
April 23, 2002
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 Arteria Medical Science, Inc.

  • K021210 — ARTERIA OCCLUSION BALLOON (October 28, 2002)
  • K001917 — PARODI CATHETER FOR ANGIOGRAPHY (PARCA) (June 6, 2001)

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)
  • 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