FDA 510(k)

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

K-Number: K962175 · 1997-01-17

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1997-01-17

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K962175. 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 ADJUSTABLE FLANGE TRACHEOSTOMY TUBE?

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K962175.

When did PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1997-01-17, under 510(k) number K962175.

Who is the listed applicant for PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE?

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

What is the FDA product code for PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE?

The FDA product code for PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE is JOH.

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Other records listing Smiths Industries Medical Systems, Inc. as applicant

K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED K965017REGIONAL ANESTHESIA TRAYS K962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT K963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)K960429PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA K953485SIMS CPAP SYSTEM

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Related Devices (Code: 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.