FDA 510(k)

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

K-Number: K873461 · 1987-11-06

Decision Date1987-11-06

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) 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 1987-11-06 under 510(k) number K873461. 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 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)?

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) is a medical device that received FDA 510(k) clearance on 1987-11-06. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K873461.

When did LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) receive FDA 510(k) clearance?

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) received FDA 510(k) clearance on 1987-11-06, under 510(k) number K873461.

Who is the listed applicant for LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)?

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 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)?

The FDA product code for LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) 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.