FDA 510(k)

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT

K-Number: K031057 · 2003-07-18

Decision Date2003-07-18

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 2003-07-18 under 510(k) number K031057. 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?

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 2003-07-18. The listed applicant is Portex, Inc.. The 510(k) number is K031057.

When did PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT receive FDA 510(k) clearance?

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT received FDA 510(k) clearance on 2003-07-18, under 510(k) number K031057.

Who is the listed applicant for PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT?

The FDA 510(k) record lists 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?

The FDA product code for PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT 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.