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FDA 510(k)

PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

K-Number: K120079 · 2012-05-24

ApplicantPrimed Halberstadt Medizintechnik GmbH
Decision Date2012-05-24
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMED TRACHEOSTOMY TUBES (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Primed Halberstadt Medizintechnik GmbH. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K120079. 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 PRIMED TRACHEOSTOMY TUBES (MULTIPLE)?

PRIMED TRACHEOSTOMY TUBES (MULTIPLE) is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Primed Halberstadt Medizintechnik GmbH. The 510(k) number is K120079.

When did PRIMED TRACHEOSTOMY TUBES (MULTIPLE) receive FDA 510(k) clearance?

PRIMED TRACHEOSTOMY TUBES (MULTIPLE) received FDA 510(k) clearance on 2012-05-24, under 510(k) number K120079.

Who is the listed applicant for PRIMED TRACHEOSTOMY TUBES (MULTIPLE)?

The FDA 510(k) record lists Primed Halberstadt Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED TRACHEOSTOMY TUBES (MULTIPLE)?

The FDA product code for PRIMED TRACHEOSTOMY TUBES (MULTIPLE) is BTO.

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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.K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULARegulatory and Marketing Services, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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