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510(k) K971348

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM by Green Field Medical Sourcing, Inc. — Product Code CAO

K971348 is an FDA 510(k) premarket notification submitted by Green Field Medical Sourcing, Inc. for the device "FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 1998. The device falls under product code CAO (Airway, Esophageal (Obturator)), a Class II device regulated under 21 CFR 868.5650. Green Field Medical Sourcing, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1998
Date Received
April 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Esophageal (Obturator)
Device Class
Class II
Regulation Number
868.5650
Review Panel
AN
Submission Type

Other clearances by Green Field Medical Sourcing, Inc.

  • K971759 — MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER (March 2, 1998)
  • K954150 — VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) (December 20, 1995)
  • K944667 — LIFE PULSE TESUSCITATION TIMER (October 4, 1994)
  • K932867 — LIFE PULSE RESUSCITATION TIMER (July 25, 1994)

Other clearances for product code CAO

  • K894032 — EVAC-TUBE (August 31, 1989)
  • K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (January 19, 1988)
  • K864200 — VETA/VENTED ESOPHAGEAL TUBE AIRWAY (March 17, 1987)
  • K863172 — RESPIRONICS PTL REVIVEEASY (November 4, 1986)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)

FDA data resources