FDA 510(k)

REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)

K-Number: K810321 · 1981-03-04

ApplicantNational Catheter Co. Div. Mallinckrodt

Decision Date1981-03-04

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) is the device name listed in this FDA 510(k) record. The listed applicant is National Catheter Co. Div. Mallinckrodt. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810321. 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 REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)?

REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K810321.

When did REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) receive FDA 510(k) clearance?

REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810321.

Who is the listed applicant for REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)?

The FDA 510(k) record lists National Catheter Co. Div. Mallinckrodt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)?

The FDA product code for REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) is BTO.

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Other records listing National Catheter Co. Div. Mallinckrodt as applicant

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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.