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FDA 510(k)

WELL LEAD TRACHEOSTOMY TUBE

K-Number: K042684 · 2005-02-17

ApplicantWell Lead Medical Instruments
Decision Date2005-02-17
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WELL LEAD TRACHEOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Instruments. It received FDA 510(k) clearance on 2005-02-17 under 510(k) number K042684. 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 WELL LEAD TRACHEOSTOMY TUBE?

WELL LEAD TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 2005-02-17. The listed applicant is Well Lead Medical Instruments. The 510(k) number is K042684.

When did WELL LEAD TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

WELL LEAD TRACHEOSTOMY TUBE received FDA 510(k) clearance on 2005-02-17, under 510(k) number K042684.

Who is the listed applicant for WELL LEAD TRACHEOSTOMY TUBE?

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

What is the FDA product code for WELL LEAD TRACHEOSTOMY TUBE?

The FDA product code for WELL LEAD TRACHEOSTOMY TUBE is BTO.

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Other records listing Well Lead Medical Instruments 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.

K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSK073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEK042683WELL LEAD ENDOTRACHEAL TUBE

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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