FDA 510(k)

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K-Number: K003315 · 2000-11-08

Decision Date2000-11-08

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt, Inc.. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K003315. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is Mallinckrodt, Inc.. The 510(k) number is K003315.

When did SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA receive FDA 510(k) clearance?

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA received FDA 510(k) clearance on 2000-11-08, under 510(k) number K003315.

Who is the listed applicant for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

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

What is the FDA product code for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

The FDA product code for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is JOH.

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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.