FDA 510(k)

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

K-Number: K032112 · 2004-01-26

Decision Date2004-01-26

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) is the device name listed in this FDA 510(k) record. The listed applicant is Portex , Ltd.. It received FDA 510(k) clearance on 2004-01-26 under 510(k) number K032112. 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 P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)?

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) is a medical device that received FDA 510(k) clearance on 2004-01-26. The listed applicant is Portex , Ltd.. The 510(k) number is K032112.

When did P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) receive FDA 510(k) clearance?

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) received FDA 510(k) clearance on 2004-01-26, under 510(k) number K032112.

Who is the listed applicant for P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)?

The FDA 510(k) record lists Portex , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)?

The FDA product code for P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) is BTR.

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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.