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510(k) K913542

THORACIC CATHETER WITH GUIDE by Intl. Medical Devices , Ltd. — Product Code GBX

K913542 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "THORACIC CATHETER WITH GUIDE". The FDA issued a decision of Substantially Equivalent on January 21, 1992. The device falls under product code GBX (Catheter, Irrigation), 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
January 21, 1992
Date Received
August 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
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)
  • 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)
  • K842666 — NU-THOR THORACOSTOMY KIT (September 20, 1984)
  • K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT (May 2, 1984)
  • K820778 — RESPIRATION MONITOR 1000 (May 3, 1982)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources