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FDA 510(k)

MODIFIED SCOOP TRANSTRACHEAL CATHETERS

K-Number: K902281 · 1990-08-10

ApplicantTranstracheal Systems
Decision Date1990-08-10
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED SCOOP TRANSTRACHEAL CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Transtracheal Systems. It received FDA 510(k) clearance on 1990-08-10 under 510(k) number K902281. 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 MODIFIED SCOOP TRANSTRACHEAL CATHETERS?

MODIFIED SCOOP TRANSTRACHEAL CATHETERS is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Transtracheal Systems. The 510(k) number is K902281.

When did MODIFIED SCOOP TRANSTRACHEAL CATHETERS receive FDA 510(k) clearance?

MODIFIED SCOOP TRANSTRACHEAL CATHETERS received FDA 510(k) clearance on 1990-08-10, under 510(k) number K902281.

Who is the listed applicant for MODIFIED SCOOP TRANSTRACHEAL CATHETERS?

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

What is the FDA product code for MODIFIED SCOOP TRANSTRACHEAL CATHETERS?

The FDA product code for MODIFIED SCOOP TRANSTRACHEAL CATHETERS is BTO.

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Other records listing Transtracheal Systems 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.

K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000K981078TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000K981080SCOOP 1K962944TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)K904748TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100K904749TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200

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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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