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FDA 510(k)

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA

K-Number: K960429 · 1996-05-02

ApplicantSmiths Industries Medical Systems, Inc.
Decision Date1996-05-02
Product CodeJOH
Advisory CommitteeAN
DecisionUnknown

Device Summary

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA 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 1996-05-02 under 510(k) number K960429. 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 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA?

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K960429.

When did PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA receive FDA 510(k) clearance?

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA received FDA 510(k) clearance on 1996-05-02, under 510(k) number K960429.

Who is the listed applicant for PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA?

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 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA?

The FDA product code for PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA is JOH.

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Other records listing Smiths Industries Medical Systems, Inc. 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.

K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFEDK965017REGIONAL ANESTHESIA TRAYSK962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBEK962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KITK963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)K953485SIMS CPAP SYSTEM

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Related Devices (Code: JOH)

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.

K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTCovidien, LLCK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbHK193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidienK193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetCook IncorporatedK182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien

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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