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510(k) K810068

PEDIATRIC ARTERIAL BLOOD FILTER by Delta Medical Industries — Product Code DTM

K810068 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "PEDIATRIC ARTERIAL BLOOD FILTER". The FDA issued a decision of Substantially Equivalent on January 22, 1981. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Delta Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

Other clearances by Delta Medical Industries

  • K833884 — ISOTEC DISPOS. PRESSURE TRANSDUCER (April 17, 1984)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K832470 — INFUSION PUMP (February 28, 1984)
  • K830389 — ACCU-RYNGE PUMP SP-250 (September 12, 1983)
  • K831750 — PM-3 (July 26, 1983)
  • K822761 — DELIVERY TUBE SET #2226 (September 30, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)
  • K803102 — ARTERIAL BUBBLE TRAP K-20 (December 22, 1980)

Other clearances for product code DTM

  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K242953 — KIDS Arterial Filters (December 20, 2024)
  • K242092 — MICRO Arterial Filters (November 18, 2024)
  • K231362 — OCS Heart Leukocyte Depleting Filter (October 31, 2023)
  • K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (March 19, 2013)
  • K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 7, 2012)
  • K121209 — TERUMO PALL AL20X ARTERIAL FILTER (May 8, 2012)
  • K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (September 29, 2011)
  • K100646 — AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 16, 2010)
  • K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (January 22, 2010)

FDA data resources