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FDA 510(k)

CUFFED TRACHEA TUBE FOR USE W/PERTRACH

K-Number: K801379 · 1980-09-09

ApplicantFrederic J. Toye, M.D.
Decision Date1980-09-09
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUFFED TRACHEA TUBE FOR USE W/PERTRACH is the device name listed in this FDA 510(k) record. The listed applicant is Frederic J. Toye, M.D.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801379. 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 CUFFED TRACHEA TUBE FOR USE W/PERTRACH?

CUFFED TRACHEA TUBE FOR USE W/PERTRACH is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Frederic J. Toye, M.D.. The 510(k) number is K801379.

When did CUFFED TRACHEA TUBE FOR USE W/PERTRACH receive FDA 510(k) clearance?

CUFFED TRACHEA TUBE FOR USE W/PERTRACH received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801379.

Who is the listed applicant for CUFFED TRACHEA TUBE FOR USE W/PERTRACH?

The FDA 510(k) record lists Frederic J. Toye, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUFFED TRACHEA TUBE FOR USE W/PERTRACH?

The FDA product code for CUFFED TRACHEA TUBE FOR USE W/PERTRACH is BTO.

Related Clinical Trials

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.

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Other records listing Frederic J. Toye, M.D. 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.

K871199MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.K822440PERCUTANEOUS CRICOTHYROIDOTOMYK832498PERCUTANEOUS TRACHEOSTOMY DEVICEK830509EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-K821821PERCUTANEOUS TRACHEOSTOMY DEVICE

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

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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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