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FDA 510(k)

LOW PROFILE TRACHEOSTOMY TUBE

K-Number: K922749 · 1992-09-02

ApplicantConcord/Portex
Decision Date1992-09-02
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE TRACHEOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K922749. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW PROFILE TRACHEOSTOMY TUBE?

LOW PROFILE TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Concord/Portex. The 510(k) number is K922749.

When did LOW PROFILE TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

LOW PROFILE TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922749.

Who is the listed applicant for LOW PROFILE TRACHEOSTOMY TUBE?

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

What is the FDA product code for LOW PROFILE TRACHEOSTOMY TUBE?

The FDA product code for LOW PROFILE TRACHEOSTOMY TUBE is BTO.

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Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSER

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Related Devices (Code: BTO)

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.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

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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