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510(k) K944685

CATO FIRST PICC-DUAL LUMEN by Catco Medical, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
September 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Catco Medical, Inc.

  • K945728 — CATCO THORACIC CATHETER (May 23, 1995)
  • K944367 — CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944410 — CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944368 — CATCO SILICONE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944336 — CATCO UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944504 — CATCO FIRST PICC (March 31, 1995)
  • K945012 — CATCO NUTRITIONAL CATHETER (February 24, 1995)
  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K945499 — CATO FIRST PICC KIT (February 7, 1995)
  • K945727 — CATCO NEONATAL PALATE GUARD (December 7, 1994)

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