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FDA 510(k)

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM

K-Number: K971348 · 1998-02-27

ApplicantGreen Field Medical Sourcing, Inc.
Decision Date1998-02-27
Product CodeCAO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Green Field Medical Sourcing, Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K971348. The device is classified under product code CAO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM?

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Green Field Medical Sourcing, Inc.. The 510(k) number is K971348.

When did FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM receive FDA 510(k) clearance?

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM received FDA 510(k) clearance on 1998-02-27, under 510(k) number K971348.

Who is the listed applicant for FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM?

The FDA 510(k) record lists Green Field Medical Sourcing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM?

The FDA product code for FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM is CAO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Green Field Medical Sourcing, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971759MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTERK954150VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)K944667LIFE PULSE TESUSCITATION TIMERK932867LIFE PULSE RESUSCITATION TIMER

Related Devices (Code: CAO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894032EVAC-TUBESharn, Inc.K875226ESOPHAGEAL OBTURATOR/TRACHEAL TUBESheridan Catheter Corp.K864200VETA/VENTED ESOPHAGEAL TUBE AIRWAYCranco Co.K863172RESPIRONICS PTL REVIVEEASYRespironics, Inc.K761195ESOPHAGEAL OBTURATION AIRWAYMckesson Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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