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FDA 510(k)

FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.

K-Number: K884427 · 1988-11-02

ApplicantBivona Medical Technologies
Decision Date1988-11-02
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K884427. 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 FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.?

FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Bivona Medical Technologies. The 510(k) number is K884427.

When did FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. receive FDA 510(k) clearance?

FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. received FDA 510(k) clearance on 1988-11-02, under 510(k) number K884427.

Who is the listed applicant for FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.?

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

What is the FDA product code for FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.?

The FDA product code for FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. is BTO.

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Other records listing Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

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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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