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510(k) K790650

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

K790650 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "WEISS EMERGENCY AIRWAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 1979. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. Intl. Medical Devices , Ltd. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • K842666 — NU-THOR THORACOSTOMY KIT (September 20, 1984)
  • K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT (May 2, 1984)

Other clearances for product code BWC

  • K200190 — ScalpelCric (October 30, 2020)
  • 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)

FDA data resources