FDA 510(k)

TRACHEOSTOMY TUBES, SHORT AND LONG TERM

K-Number: K791044 · 1979-06-13

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1979-06-13

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY TUBES, SHORT AND LONG TERM is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1979-06-13 under 510(k) number K791044. 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 TRACHEOSTOMY TUBES, SHORT AND LONG TERM?

TRACHEOSTOMY TUBES, SHORT AND LONG TERM is a medical device that received FDA 510(k) clearance on 1979-06-13. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K791044.

When did TRACHEOSTOMY TUBES, SHORT AND LONG TERM receive FDA 510(k) clearance?

TRACHEOSTOMY TUBES, SHORT AND LONG TERM received FDA 510(k) clearance on 1979-06-13, under 510(k) number K791044.

Who is the listed applicant for TRACHEOSTOMY TUBES, SHORT AND LONG TERM?

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

What is the FDA product code for TRACHEOSTOMY TUBES, SHORT AND LONG TERM?

The FDA product code for TRACHEOSTOMY TUBES, SHORT AND LONG TERM is BTO.

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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.