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FDA 510(k)

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

K-Number: K041348 · 2004-07-13

ApplicantSmiths Medical
Decision Date2004-07-13
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical. It received FDA 510(k) clearance on 2004-07-13 under 510(k) number K041348. 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 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA?

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA is a medical device that received FDA 510(k) clearance on 2004-07-13. The listed applicant is Smiths Medical. The 510(k) number is K041348.

When did PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA receive FDA 510(k) clearance?

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA received FDA 510(k) clearance on 2004-07-13, under 510(k) number K041348.

Who is the listed applicant for PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA?

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

What is the FDA product code for PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA?

The FDA product code for PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA is JOH.

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Other records listing Smiths Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181660Acapella Choice Blue Vibratory PEP DeviceK050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

Related Devices (Code: 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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