FDA 510(k)

PERCUTANEOUS TRACHEOSTOMY KIT

K-Number: K936133 · 1994-03-23

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1994-03-23

Product CodeJOH

Advisory CommitteeAN

DecisionUnknown

Device Summary

PERCUTANEOUS TRACHEOSTOMY KIT 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 1994-03-23 under 510(k) number K936133. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PERCUTANEOUS TRACHEOSTOMY KIT?

PERCUTANEOUS TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K936133.

When did PERCUTANEOUS TRACHEOSTOMY KIT receive FDA 510(k) clearance?

PERCUTANEOUS TRACHEOSTOMY KIT received FDA 510(k) clearance on 1994-03-23, under 510(k) number K936133.

Who is the listed applicant for PERCUTANEOUS TRACHEOSTOMY KIT?

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 PERCUTANEOUS TRACHEOSTOMY KIT?

The FDA product code for PERCUTANEOUS TRACHEOSTOMY KIT 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 K962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE 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

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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.