FDA 510(k)

DOUBLE LUMEN TRACHEAL TUBE

K-Number: K802505 · 1981-03-13

ApplicantNational Catheter Co. Div. Mallinckrodt

Decision Date1981-03-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DOUBLE LUMEN TRACHEAL TUBE 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 1981-03-13 under 510(k) number K802505. 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 DOUBLE LUMEN TRACHEAL TUBE?

DOUBLE LUMEN TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K802505.

When did DOUBLE LUMEN TRACHEAL TUBE receive FDA 510(k) clearance?

DOUBLE LUMEN TRACHEAL TUBE received FDA 510(k) clearance on 1981-03-13, under 510(k) number K802505.

Who is the listed applicant for DOUBLE LUMEN TRACHEAL TUBE?

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 DOUBLE LUMEN TRACHEAL TUBE?

The FDA product code for DOUBLE LUMEN TRACHEAL TUBE is BTR.

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

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Related Devices (Code: 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.