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FDA 510(k)

TRACH TAPE

K-Number: K820099 · 1982-02-23

ApplicantStan-Pak Ent.
Decision Date1982-02-23
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Stan-Pak Ent.. It received FDA 510(k) clearance on 1982-02-23 under 510(k) number K820099. 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 TRACH TAPE?

TRACH TAPE is a medical device that received FDA 510(k) clearance on 1982-02-23. The listed applicant is Stan-Pak Ent.. The 510(k) number is K820099.

When did TRACH TAPE receive FDA 510(k) clearance?

TRACH TAPE received FDA 510(k) clearance on 1982-02-23, under 510(k) number K820099.

Who is the listed applicant for TRACH TAPE?

The FDA 510(k) record lists Stan-Pak Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACH TAPE?

The FDA product code for TRACH TAPE 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.

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Other records listing Stan-Pak Ent. 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.

K823058DOSOMETRIC RELEASE STERILIZATIONK820100FROSTED GLASS SLIDESK820108TOPPER SPONGESK820140WEBRIL CAST PADDINGK820155SPECIALIST CAST PADDINGK820106X-RAY GUAZE SPONGES

View all 20 devices →

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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