FDA 510(k)

BIVONA TRACHEAL T-TUBE STENT

K-Number: K920604 · 1992-07-27

Decision Date1992-07-27

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA TRACHEAL T-TUBE STENT is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1992-07-27 under 510(k) number K920604. 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 BIVONA TRACHEAL T-TUBE STENT?

BIVONA TRACHEAL T-TUBE STENT is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Bivona Medical Technologies. The 510(k) number is K920604.

When did BIVONA TRACHEAL T-TUBE STENT receive FDA 510(k) clearance?

BIVONA TRACHEAL T-TUBE STENT received FDA 510(k) clearance on 1992-07-27, under 510(k) number K920604.

Who is the listed applicant for BIVONA TRACHEAL T-TUBE STENT?

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIVONA TRACHEAL T-TUBE STENT?

The FDA product code for BIVONA TRACHEAL T-TUBE STENT is BTO.

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Other records listing Bivona Medical Technologies as applicant

K952700SUPERSLICK K942025BURGET NASAL STENT K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES K935053BIVONA NASAL TURBINATE STENT K933398BIVONA ILLUMINATED ENDOTRACHEAL TUBE K931749BIVONA(R) ICU ENDOTRACHEAL TUBE

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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.