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510(k) K070320

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 by Edwards Lifesciences Services GmbH — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2007
Date Received
February 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Edwards Lifesciences Services GmbH

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  • K063293 — EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWAR (March 23, 2007)

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  • K243505 — 5008X Hemodialysis System (May 30, 2025)
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  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)