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510(k) K935641

0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS by Evans Medical, Inc. — Product Code FPB

K935641 is an FDA 510(k) premarket notification submitted by Evans Medical, Inc. for the device "0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Evans Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
November 22, 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 Evans Medical, Inc.

  • K020530 — EVANS SUB-Q, MODEL MC4206 (April 29, 2002)
  • K935480 — MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS (January 28, 1994)
  • K935642 — EVANS MEDICAL EXTENSION SETS (January 28, 1994)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (August 31, 2026)
  • 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)

FDA data resources