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FDA 510(k)

FAST TRACT TRANSTRACHEAL PROCEDURE KIT

K-Number: K970018 · 1997-03-28

ApplicantL.W. Ward and Assoc., Inc.
Decision Date1997-03-28
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FAST TRACT TRANSTRACHEAL PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is L.W. Ward and Assoc., Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K970018. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAST TRACT TRANSTRACHEAL PROCEDURE KIT?

FAST TRACT TRANSTRACHEAL PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is L.W. Ward and Assoc., Inc.. The 510(k) number is K970018.

When did FAST TRACT TRANSTRACHEAL PROCEDURE KIT receive FDA 510(k) clearance?

FAST TRACT TRANSTRACHEAL PROCEDURE KIT received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970018.

Who is the listed applicant for FAST TRACT TRANSTRACHEAL PROCEDURE KIT?

The FDA 510(k) record lists L.W. Ward and Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAST TRACT TRANSTRACHEAL PROCEDURE KIT?

The FDA product code for FAST TRACT TRANSTRACHEAL PROCEDURE KIT is LRC.

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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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