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510(k) K083747

TERUMO PALL AL3X ARTERIAL FILTER by Terumo Cardiovascular Systems Corp. — Product Code DTM

K083747 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "TERUMO PALL AL3X ARTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on August 20, 2009. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2009
Date Received
December 17, 2008
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 Terumo Cardiovascular Systems Corp.

  • K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenato (December 2, 2015)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K131041 — ADVANCED PERFUSION SYSTEM 1 (February 20, 2014)
  • K132451 — SARNS SOFT-FLOW AORTIC CANNULA (February 18, 2014)
  • K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA (February 3, 2014)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) (February 7, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)

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