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510(k) K790650

WEISS EMERGENCY AIRWAY SYSTEM by Intl. Medical Devices , Ltd. — Product Code BWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1979
Date Received
April 3, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type

Other clearances by Intl. Medical Devices , Ltd.

  • K913540 — PEDIA-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913541 — NEO-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913542 — THORACIC CATHETER WITH GUIDE (January 21, 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)

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  • K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr (February 17, 2017)
  • K153761 — Emergency Transtracheal Airway Catheter (September 22, 2016)
  • K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (November 6, 2013)
  • K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (May 26, 2005)
  • K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (December 20, 2001)
  • K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (October 9, 2001)
  • K962312 — KEY CHAIN EMERGENCY AIRWAY (June 17, 1997)