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510(k) K945728

CATCO THORACIC CATHETER by Catco Medical, Inc. — Product Code JOL

K945728 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATCO THORACIC CATHETER". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Catco Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
November 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Catco Medical, Inc.

  • K944336 — CATCO UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944410 — CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944367 — CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944368 — CATCO SILICONE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944685 — CATO FIRST PICC-DUAL LUMEN (March 31, 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)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources