Decision Date2010-06-11
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH is the device name listed in this FDA 510(k) record. The listed applicant is Vitaltec Corporation. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K100480. 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 ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH?
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Vitaltec Corporation. The 510(k) number is K100480.
When did ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH receive FDA 510(k) clearance?
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH received FDA 510(k) clearance on 2010-06-11, under 510(k) number K100480.
Who is the listed applicant for ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH?
The FDA 510(k) record lists Vitaltec Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH?
The FDA product code for ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH 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.
Other records listing Vitaltec Corporation 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.
K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)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 6.0-10.0mm
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.