FDA 510(k)

RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET

K-Number: K122235 · 2013-09-06

Decision Date2013-09-06

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K122235. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET?

RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K122235.

When did RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET receive FDA 510(k) clearance?

RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET received FDA 510(k) clearance on 2013-09-06, under 510(k) number K122235.

Who is the listed applicant for RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET?

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

What is the FDA product code for RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET?

The FDA product code for RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET is JOH.

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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.