FDA 510(k)

VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY

K-Number: K853502 · 1985-10-01

Decision Date1985-10-01

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY 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 1985-10-01 under 510(k) number K853502. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY?

VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY is a medical device that received FDA 510(k) clearance on 1985-10-01. The listed applicant is Bivona Medical Technologies. The 510(k) number is K853502.

When did VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY receive FDA 510(k) clearance?

VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY received FDA 510(k) clearance on 1985-10-01, under 510(k) number K853502.

Who is the listed applicant for VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY?

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 VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY?

The FDA product code for VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY is BTR.

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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.