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FDA 510(k)

TRACHEAL TUBE 16 GAUGE-1.65MM-

K-Number: K832466 · 1984-09-19

ApplicantErie Medical
Decision Date1984-09-19
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEAL TUBE 16 GAUGE-1.65MM- is the device name listed in this FDA 510(k) record. The listed applicant is Erie Medical. It received FDA 510(k) clearance on 1984-09-19 under 510(k) number K832466. 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 TRACHEAL TUBE 16 GAUGE-1.65MM-?

TRACHEAL TUBE 16 GAUGE-1.65MM- is a medical device that received FDA 510(k) clearance on 1984-09-19. The listed applicant is Erie Medical. The 510(k) number is K832466.

When did TRACHEAL TUBE 16 GAUGE-1.65MM- receive FDA 510(k) clearance?

TRACHEAL TUBE 16 GAUGE-1.65MM- received FDA 510(k) clearance on 1984-09-19, under 510(k) number K832466.

Who is the listed applicant for TRACHEAL TUBE 16 GAUGE-1.65MM-?

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

What is the FDA product code for TRACHEAL TUBE 16 GAUGE-1.65MM-?

The FDA product code for TRACHEAL TUBE 16 GAUGE-1.65MM- is BTO.

Related Clinical Trials

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.

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Other records listing Erie Medical 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.

K861865ERIE-NEBK853051TRACHEAL TUBESK853039PRESSURE REGULATORK853040PRESSURE GAUGE

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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