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FDA 510(k)

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

K-Number: K060945 · 2006-06-19

ApplicantSmiths Medical International
Decision Date2006-06-19
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical International. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K060945. 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 PORTEX PERCUTANEOUS TRACHEOSTOMY KIT?

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Smiths Medical International. The 510(k) number is K060945.

When did PORTEX PERCUTANEOUS TRACHEOSTOMY KIT receive FDA 510(k) clearance?

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT received FDA 510(k) clearance on 2006-06-19, under 510(k) number K060945.

Who is the listed applicant for PORTEX PERCUTANEOUS TRACHEOSTOMY KIT?

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

What is the FDA product code for PORTEX PERCUTANEOUS TRACHEOSTOMY KIT?

The FDA product code for PORTEX PERCUTANEOUS TRACHEOSTOMY KIT 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.

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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