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FDA 510(k)

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS

K-Number: K022212 · 2003-03-21

ApplicantMentor Medical Limited
Decision Date2003-03-21
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Medical Limited. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K022212. 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 PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS?

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Mentor Medical Limited. The 510(k) number is K022212.

When did PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS receive FDA 510(k) clearance?

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS received FDA 510(k) clearance on 2003-03-21, under 510(k) number K022212.

Who is the listed applicant for PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS?

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

What is the FDA product code for PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS?

The FDA product code for PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS 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.

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