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510(k) K821328

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP by Medionics International , Ltd. — Product Code KPF

K821328 is an FDA 510(k) premarket notification submitted by Medionics International , Ltd. for the device "C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Medionics International , Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medionics International , Ltd.

  • K130441 — FALLER STYLET (April 19, 2013)
  • K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (April 28, 2000)
  • K994218 — EASY CARE AND TUBING SETS (February 10, 2000)
  • K945567 — QC CAP (February 7, 1995)
  • 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)

Other clearances for product code KPF

  • K061515 — RENALSOFT (September 11, 2006)
  • K990953 — RENAL LINK (June 18, 1999)
  • K970989 — CYBERREN (July 24, 1997)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K913515 — TOTAL CONTAINMENT DEVICE (May 26, 1994)
  • K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM (February 19, 1988)
  • K874020 — ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE (January 29, 1988)
  • K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR (December 18, 1980)
  • K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (July 21, 1980)
  • K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (December 6, 1979)

FDA data resources