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510(k) K941628

40 MICRON BLOOD TRANSFUSION FILTER by Douglas Medical Products Corp. — Product Code FPB

K941628 is an FDA 510(k) premarket notification submitted by Douglas Medical Products Corp. for the device "40 MICRON BLOOD TRANSFUSION FILTER". The FDA issued a decision of Substantially Equivalent on February 16, 1995. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Douglas Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
April 4, 1994
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 Douglas Medical Products Corp.

  • K162951 — TUBETECH IV Administration Set (July 28, 2017)
  • K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 (June 18, 1996)
  • K954428 — SOLOPICC 24 (60CM) 20GA CATHETER (March 28, 1996)
  • K942101 — 4-LEAD IRRIGATION SET (September 30, 1994)
  • K941453 — CHECK VALVE SOLUTION SET (August 16, 1994)
  • K930854 — SOLUTION SET WITH .2 MICRON FILTER (January 14, 1994)
  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

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)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources