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FDA 510(k)

MODIFIED ADULT CRICOTHYROIDOTOMY KIT

K-Number: K885139 · 1989-05-25

ApplicantPertrach
Decision Date1989-05-25
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED ADULT CRICOTHYROIDOTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pertrach. It received FDA 510(k) clearance on 1989-05-25 under 510(k) number K885139. 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 ADULT CRICOTHYROIDOTOMY KIT?

MODIFIED ADULT CRICOTHYROIDOTOMY KIT is a medical device that received FDA 510(k) clearance on 1989-05-25. The listed applicant is Pertrach. The 510(k) number is K885139.

When did MODIFIED ADULT CRICOTHYROIDOTOMY KIT receive FDA 510(k) clearance?

MODIFIED ADULT CRICOTHYROIDOTOMY KIT received FDA 510(k) clearance on 1989-05-25, under 510(k) number K885139.

Who is the listed applicant for MODIFIED ADULT CRICOTHYROIDOTOMY KIT?

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

What is the FDA product code for MODIFIED ADULT CRICOTHYROIDOTOMY KIT?

The FDA product code for MODIFIED ADULT CRICOTHYROIDOTOMY KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pertrach 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.

K914743EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF

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

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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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