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510(k) K062429

MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH by Edwards Lifesciences Research Medical — Product Code DTM

K062429 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Research Medical for the device "MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH". The FDA issued a decision of Substantially Equivalent on September 27, 2006. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Edwards Lifesciences Research Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2006
Date Received
August 21, 2006
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 Edwards Lifesciences Research Medical

  • K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA (January 31, 2008)
  • K990396 — T-ANASTAFLO (October 1, 1999)
  • K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (July 2, 1999)
  • K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (June 11, 1999)
  • K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (December 1, 1998)

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