Home / 510(k) Clearances / K761051

510(k) K761051

BI-FLOW NEEDLE by Dws, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1976
Date Received
November 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dws, Inc.

  • K231142 — Temporis, Irix Plus (April 25, 2024)
  • K761050 — HEPARIN PUMP (December 30, 1976)

Other clearances for product code KOC

  • K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K231589 — Blood Tubing Lines for Hemodialysis AV06C-E (July 28, 2023)
  • K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for (June 16, 2023)
  • K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and In (September 18, 2020)
  • K172238 — CAREline Airless Hemodialysis Blood Tubing Sets (December 14, 2017)
  • K160749 — CRIT-LINE III Blood Chamber II (April 15, 2016)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)