FDA 510(k)

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K-Number: K101721 · 2011-03-24

ApplicantRegulatory and Marketing Services, Inc.

Decision Date2011-03-24

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory and Marketing Services, Inc.. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K101721. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Regulatory and Marketing Services, Inc.. The 510(k) number is K101721.

When did WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA receive FDA 510(k) clearance?

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA received FDA 510(k) clearance on 2011-03-24, under 510(k) number K101721.

Who is the listed applicant for WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

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

What is the FDA product code for WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

The FDA product code for WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is BTO.

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Related Devices (Code: BTO)

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Official Source

View on FDA Database →

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