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FDA 510(k)

TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL

K-Number: K924191 · 1993-04-02

ApplicantAmerican Healthcare Corp.
Decision Date1993-04-02
Product CodeBTO
Advisory CommitteeAN
DecisionUnknown

Device Summary

TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Corp.. It received FDA 510(k) clearance on 1993-04-02 under 510(k) number K924191. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL?

TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL is a medical device that received FDA 510(k) clearance on 1993-04-02. The listed applicant is American Healthcare Corp.. The 510(k) number is K924191.

When did TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL receive FDA 510(k) clearance?

TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL received FDA 510(k) clearance on 1993-04-02, under 510(k) number K924191.

Who is the listed applicant for TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL?

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

What is the FDA product code for TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL?

The FDA product code for TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL is BTO.

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Other records listing American Healthcare Corp. 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.

K924192I.V. START KIT (AHC-50-54954K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEK923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERK923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEK923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERK924193TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)

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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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