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FDA 510(k)

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K-Number: K980466 · 1998-02-24

ApplicantSims Portex, Inc.
Decision Date1998-02-24
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K980466. 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 PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Sims Portex, Inc.. The 510(k) number is K980466.

When did PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA receive FDA 510(k) clearance?

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA received FDA 510(k) clearance on 1998-02-24, under 510(k) number K980466.

Who is the listed applicant for PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

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

What is the FDA product code for PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA?

The FDA product code for PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA is JOH.

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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.

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