Home / 510(k) Clearances / K945258

510(k) K945258

CATCO URINARY COLLECTION KIT by Catco Medical, Inc. — Product Code FCN

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
February 16, 1995
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Drainage Collection Kit, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Catco Medical, Inc.

  • K945728 — CATCO THORACIC CATHETER (May 23, 1995)
  • K944368 — CATCO SILICONE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944410 — CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944336 — CATCO UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944367 — CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944504 — CATCO FIRST PICC (March 31, 1995)
  • K944685 — CATO FIRST PICC-DUAL LUMEN (March 31, 1995)
  • K945012 — CATCO NUTRITIONAL CATHETER (February 24, 1995)
  • K945499 — CATO FIRST PICC KIT (February 7, 1995)
  • K945727 — CATCO NEONATAL PALATE GUARD (December 7, 1994)

Other clearances for product code FCN

  • K951443 — STANDARD FOLEY SYSTEM PAK (June 15, 1995)
  • K915166 — MICROCYCLER (September 7, 1994)
  • K922346 — FEMALE URINE SAMPLING DEVICE (August 14, 1992)
  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)