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FDA 510(k)

MONTGOMERY SILICONE TRACHEAL T-TUBE

K-Number: K810978 · 1981-05-05

ApplicantBoston Medical Products, Inc.
Decision Date1981-05-05
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONTGOMERY SILICONE TRACHEAL T-TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K810978. 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 MONTGOMERY SILICONE TRACHEAL T-TUBE?

MONTGOMERY SILICONE TRACHEAL T-TUBE is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K810978.

When did MONTGOMERY SILICONE TRACHEAL T-TUBE receive FDA 510(k) clearance?

MONTGOMERY SILICONE TRACHEAL T-TUBE received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810978.

Who is the listed applicant for MONTGOMERY SILICONE TRACHEAL T-TUBE?

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

What is the FDA product code for MONTGOMERY SILICONE TRACHEAL T-TUBE?

The FDA product code for MONTGOMERY SILICONE TRACHEAL T-TUBE is BTO.

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Other records listing Boston Medical Products, Inc. as applicant

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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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