FDA 510(k)

UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)

K-Number: K862666 · 1986-08-01

Decision Date1986-08-01

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862666. 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 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)?

UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K862666.

When did UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) receive FDA 510(k) clearance?

UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862666.

Who is the listed applicant for UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)?

The FDA product code for UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) is BTR.

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Related Devices (Code: BTR)

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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.