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510(k) K935958

CRIT-LINE BLOOD CHAMBER WITH E-BEAM by In-Line Diagnostics Corp. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1995
Date Received
November 26, 1993
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 In-Line Diagnostics Corp.

  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)
  • K972470 — CRIT-LINE MONITOR (CLMIII) (December 11, 1997)
  • K953875 — CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) (July 23, 1996)
  • K950942 — CRIT-LINE HEMATOCRIT ALERT (March 14, 1995)

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  • 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)