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510(k) K860155

PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 by Medical Components, Inc. — Product Code FKO

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 14, 1986
Date Received
January 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal Dialysis, Single Use
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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Other clearances for product code FKO

  • K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (June 26, 1998)
  • K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR (February 27, 1998)
  • K910787 — TITANIUM CONNECTOR (2 PART) (August 15, 1991)
  • K885037 — AMUKIN 50% - AIRSPRAY(R) (October 19, 1990)
  • K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (December 9, 1987)
  • K872221 — DIALY-NATE SET & DIALY-NATE CATHETER (October 13, 1987)
  • K871730 — MODIFIED USE OF PULL-APART INTRODUCER SET (May 18, 1987)
  • K870472 — ACUTE PERITONEAL DIALYSIS KIT (February 25, 1987)
  • K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS (January 9, 1986)
  • K845041 — CAPD STAGED CONNECTOR (February 21, 1985)