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510(k) K854966

ACUTE PERITONEAL DIALYSIS CATHETERS by Thermedics, Inc. — Product Code FKO

K854966 is an FDA 510(k) premarket notification submitted by Thermedics, Inc. for the device "ACUTE PERITONEAL DIALYSIS CATHETERS". The FDA issued a decision of Substantially Equivalent on January 9, 1986. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Thermedics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1986
Date Received
December 11, 1985
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

Other clearances by Thermedics, Inc.

  • K894131 — DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 (September 26, 1989)
  • K863128 — PERITONEAL DIALYSIS CATHETERS (September 9, 1986)
  • K850076 — WOUND DRESSING MODEL ZB-6 (April 15, 1985)

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)
  • K860155 — PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 (February 14, 1986)
  • K845041 — CAPD STAGED CONNECTOR (February 21, 1985)

FDA data resources