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FDA 510(k)

CRICOTHYROTOMY TUBE

K-Number: K983000 · 1999-10-27

ApplicantPolamedco, Inc.
Decision Date1999-10-27
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRICOTHYROTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1999-10-27 under 510(k) number K983000. 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 CRICOTHYROTOMY TUBE?

CRICOTHYROTOMY TUBE is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Polamedco, Inc.. The 510(k) number is K983000.

When did CRICOTHYROTOMY TUBE receive FDA 510(k) clearance?

CRICOTHYROTOMY TUBE received FDA 510(k) clearance on 1999-10-27, under 510(k) number K983000.

Who is the listed applicant for CRICOTHYROTOMY TUBE?

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

What is the FDA product code for CRICOTHYROTOMY TUBE?

The FDA product code for CRICOTHYROTOMY TUBE is BTO.

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Other records listing Polamedco, Inc. 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.

K954383SURELOC CIRCUIT CONNECTORK953793INTROSCOPEK950713AIRGUIDE STYLETTEK933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONK950380FLEXTITIP STYLETTEK920900POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

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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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