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510(k) K013418

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY by Asahi Medical Co., Ltd. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2002
Date Received
October 15, 2001
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 Asahi Medical Co., Ltd.

  • K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MOD (July 23, 2004)
  • K001250 — APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (August 16, 2000)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)
  • K914020 — MODIFIED ASAHI PAN-SERIES HEMOFILTERS (March 20, 1992)
  • K901887 — MODIFIED SEPACELL R-SERIES BLOOD FILTERS (August 8, 1990)
  • K896664 — MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT (January 24, 1990)
  • K896976 — MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS (January 24, 1990)
  • K892374 — NEW AM-SERIES DIALYZERS (May 18, 1989)

Other clearances for product code KDI

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  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • 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)