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FDA 510(k)

Pilling Tracheostomy Tubes

K-Number: K233713 · 2024-03-22

ApplicantTeleflex Medical
Decision Date2024-03-22
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pilling Tracheostomy Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2024-03-22 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K233713.

When did Pilling Tracheostomy Tubes receive FDA 510(k) clearance?

Pilling Tracheostomy Tubes received FDA 510(k) clearance on 2024-03-22, under 510(k) number K233713.

Who is the listed applicant for Pilling Tracheostomy Tubes?

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

What is the FDA product code for Pilling Tracheostomy Tubes?

The FDA product code for Pilling Tracheostomy Tubes is BTO.

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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.

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 CorporationK192511Venner 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.

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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