FDA 510(k)

RUSCH TRACHEOFIX-SET

K-Number: K972423 · 1998-02-13

Decision Date1998-02-13

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RUSCH TRACHEOFIX-SET is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K972423. 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 TRACHEOFIX-SET?

RUSCH TRACHEOFIX-SET is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Rusch Intl.. The 510(k) number is K972423.

When did RUSCH TRACHEOFIX-SET receive FDA 510(k) clearance?

RUSCH TRACHEOFIX-SET received FDA 510(k) clearance on 1998-02-13, under 510(k) number K972423.

Who is the listed applicant for RUSCH TRACHEOFIX-SET?

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

What is the FDA product code for RUSCH TRACHEOFIX-SET?

The FDA product code for RUSCH TRACHEOFIX-SET is JOH.

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Other records listing Rusch Intl. as applicant

K033023INTERMITTENT URETHRAL CATHETERS K030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM K023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETER K023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS K023964RUSCH MICROLARYNGEAL TUBE K021540RUSCH EDGAR TUBE

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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.