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510(k) K945567

QC CAP by Medionics International, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
September 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medionics International, Inc.

  • K130441 — FALLER STYLET (April 19, 2013)
  • K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (April 28, 2000)
  • K994218 — EASY CARE AND TUBING SETS (February 10, 2000)
  • K910173 — SELECTRA AND TUBING SETS (January 13, 1992)
  • K883393 — CAPD DISPOSABLE Y SYSTEM - DY SET (November 3, 1988)
  • K842305 — C.A.P.D. AUTOMATIC HEATER PDH 200 (June 25, 1984)
  • K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER (October 14, 1983)
  • K831766 — MICROSTAR VCI (October 14, 1983)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

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  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
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