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510(k) K853345

31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE by 31st. Centruy Medical Corp. — Product Code BWC

K853345 is an FDA 510(k) premarket notification submitted by 31st. Centruy Medical Corp. for the device "31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE". The FDA issued a decision of Substantially Equivalent on October 1, 1985. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1985
Date Received
August 12, 1985
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 for product code BWC

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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)

FDA data resources