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510(k) K810600

CAPD EXCHANGE SET by American Mcgaw — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1981
Date Received
March 6, 1981
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 American Mcgaw

  • K853549 — MCGAW/DROP WATCH FLOW MONITOR (November 12, 1985)
  • K843639 — ADD-A-VIAL SOLUTION TRANSFER DEVICE (January 14, 1985)
  • K843954 — MIXING CONTAINER (November 28, 1984)
  • K841729 — ACCUPRO ENTERAL FEEDING PUMP (June 1, 1984)
  • K840388 — PAB IV CONTAINER (March 6, 1984)
  • K840212 — CONCENTRATED PLATELET ADMIN. SET (March 6, 1984)
  • K831716 — CAPD - CATHETER ADAPTER (June 24, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)
  • K820133 — MCGAW FAT EMULSION SET (April 6, 1982)
  • K813092 — ACCUPRO I.V. ADMINISTRATION SET (December 31, 1981)

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  • 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)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)