Decision Date2024-03-22
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Pilling Tracheostomy Tubes is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2024-03-22 under approval number K233713. 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 Pilling Tracheostomy Tubes?
Pilling Tracheostomy Tubes is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Teleflex Medical. The 510(k) number is K233713.
When was Pilling Tracheostomy Tubes approved by the FDA?
Pilling Tracheostomy Tubes received FDA 510(k) clearance on 2024-03-22, under approval number K233713.
What company makes Pilling Tracheostomy Tubes?
Pilling Tracheostomy Tubes is manufactured by Teleflex Medical.
What is the FDA product code for Pilling Tracheostomy Tubes?
The FDA product code for Pilling Tracheostomy Tubes is BTO.
Related Devices (Code: BTO)
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K192511Venner 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.
K2429215300600-5301000 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 Corporation
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.