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FDA 510(k)

Portex Blue Line Ultra Paediatric Tracheosomy Tube

K-Number: K170720 · 2017-12-07

ApplicantSmiths Medical Asd, Inc.
Decision Date2017-12-07
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portex Blue Line Ultra Paediatric Tracheosomy Tube is a medical device manufactured by Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2017-12-07 under approval number K170720. 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 Blue Line Ultra Paediatric Tracheosomy Tube?

Portex Blue Line Ultra Paediatric Tracheosomy Tube is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Smiths Medical Asd, Inc.. The 510(k) number is K170720.

When was Portex Blue Line Ultra Paediatric Tracheosomy Tube approved by the FDA?

Portex Blue Line Ultra Paediatric Tracheosomy Tube received FDA 510(k) clearance on 2017-12-07, under approval number K170720.

What company makes Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Portex Blue Line Ultra Paediatric Tracheosomy Tube is manufactured by Smiths Medical Asd, Inc..

What is the FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

The FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube 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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