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FDA 510(k)

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT

K-Number: K083031 · 2009-08-18

ApplicantSmiths Medical Asd, Inc.
Decision Date2009-08-18
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2009-08-18 under 510(k) number K083031. 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 UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT?

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 2009-08-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K083031.

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

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT received FDA 510(k) clearance on 2009-08-18, under 510(k) number K083031.

Who is the listed applicant for PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT?

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

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

The FDA product code for PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT is BTO.

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Other records listing Smiths Medical Asd, Inc. as applicant

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K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaK211634Hypodermic Needle-Pro EDGE Safety DeviceK192375Intellifuse Administration and Intellifuse Blood Administration SetsK181699Level 1 Convective WarmerK172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

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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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