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510(k) Data Aggregation
K Number
K971348Device Name
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
Manufacturer
GREEN FIELD MEDICAL SOURCING, INC.
Date Cleared
1998-02-27
(323 days)
Product Code
CAO
Regulation Number
868.5650Why did this record match?
Product Code :
CAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest.
- 2. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient. *
- To establish a patent airway in a conscious patient who is unable to ventilate 3. adequately. *
- 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. *
- 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible.
- 6. Where either tracheal or esophageal obturator airway is indicated.
- 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required.
- 8. For use by a person trained and experienced in airway management and the use of this device.
Device Description
FastTrach Single-Pass Trachea1/Esophagea1 Airway System
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