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510(k) K964922

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM by Althin Medical AB an Affiliate of Baxter Intl — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1997
Date Received
December 9, 1996
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 Althin Medical AB an Affiliate of Baxter Intl

  • K990643 — PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 (December 7, 1999)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970681 — ALTRA NOVA 200 HEMODIALYZER (July 23, 1998)
  • K970446 — DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (June 2, 1997)
  • K955384 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN (January 10, 1997)
  • K962309 — ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS (December 27, 1996)
  • K954987 — ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM (August 8, 1996)
  • K952983 — ALTR NOVA 110 HEMODIALYZER (October 5, 1995)
  • K952982 — ALTREX 110 HEMODIALYZER (October 5, 1995)
  • K952978 — ALTRA FLUX 110 HEMODIALYZER (October 5, 1995)

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)