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510(k) K861106

FRESENIUS HEMOFLOW F80 DIALYZER by Seratronics, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
March 24, 1986
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 Seratronics, Inc.

  • K955299 — DPS 4 DIALYZER PREPARATION SYSTEM (October 21, 1996)
  • K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM (April 18, 1996)
  • K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM (November 29, 1995)
  • K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (August 29, 1994)
  • K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM (February 24, 1992)
  • K874573 — FRESENIUS PURISTERIL 340 (TM) (April 25, 1988)
  • K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7 (February 19, 1988)
  • K870725 — FRESENIUS HEMOFLOW F6 AND F8 (May 1, 1987)
  • K870724 — FRESENIUS HEMOFLOW F60 AND F80 (April 1, 1987)
  • K864587 — FRESENIUS ULTRAFLUX AV400, AV600 (March 3, 1987)

Other clearances for product code KDI

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • 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)