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510(k) K842666

NU-THOR THORACOSTOMY KIT by Intl. Medical Devices , Ltd. — Product Code KGZ

K842666 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "NU-THOR THORACOSTOMY KIT". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Intl. Medical Devices , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Intl. Medical Devices , Ltd.

  • K913541 — NEO-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913540 — PEDIA-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913539 — THORACIC CATHTER STYLET (January 21, 1992)
  • K913542 — THORACIC CATHETER WITH GUIDE (January 21, 1992)
  • K913543 — THORACIC CATHETER STYLET (October 4, 1991)
  • K862909 — RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM (September 9, 1986)
  • K850398 — NU-CATH EMERGENCY KIT (March 27, 1985)
  • K843785 — WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR (October 23, 1984)
  • K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT (May 2, 1984)
  • K820778 — RESPIRATION MONITOR 1000 (May 3, 1982)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)

FDA data resources