FDA 510(k)

AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE

K-Number: K872366 · 1987-08-17

Decision Date1987-08-17

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE 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 1987-08-17 under 510(k) number K872366. 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 AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE?

AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1987-08-17. The listed applicant is Bivona Medical Technologies. The 510(k) number is K872366.

When did AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1987-08-17, under 510(k) number K872366.

Who is the listed applicant for AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE?

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 AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE?

The FDA product code for AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE 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.