FDA 510(k)

TRACHEOSTOMA VENT

K-Number: K810436 · 1981-03-04

Decision Date1981-03-04

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMA VENT 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 1981-03-04 under 510(k) number K810436. 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 TRACHEOSTOMA VENT?

TRACHEOSTOMA VENT is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Bivona Medical Technologies. The 510(k) number is K810436.

When did TRACHEOSTOMA VENT receive FDA 510(k) clearance?

TRACHEOSTOMA VENT received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810436.

Who is the listed applicant for TRACHEOSTOMA VENT?

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 TRACHEOSTOMA VENT?

The FDA product code for TRACHEOSTOMA VENT is BTO.

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Other records listing Bivona Medical Technologies as applicant

K952700SUPERSLICK K942025BURGET NASAL STENT K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES K935053BIVONA NASAL TURBINATE STENT K933398BIVONA ILLUMINATED ENDOTRACHEAL TUBE K931749BIVONA(R) ICU ENDOTRACHEAL TUBE

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Related Devices (Code: BTO)

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 Corporation K2429215300600-5301000 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 Corporation K233713Pilling Tracheostomy TubesTeleflex Medical K192511Venner 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.