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FDA 510(k)

TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)

K-Number: K862436 · 1986-11-03

ApplicantAcutronic Medical Systems AG
Decision Date1986-11-03
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) is the device name listed in this FDA 510(k) record. The listed applicant is Acutronic Medical Systems AG. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K862436. 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 TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)?

TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K862436.

When did TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) receive FDA 510(k) clearance?

TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) received FDA 510(k) clearance on 1986-11-03, under 510(k) number K862436.

Who is the listed applicant for TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)?

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

What is the FDA product code for TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)?

The FDA product code for TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) is BTO.

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Other records listing Acutronic Medical Systems AG as applicant

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K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESK012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIESK936009AMS 3000MK900745VS-200S JET VENTILATORK900744AMS 3000 PORTABLE JET VENTILATORK883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010

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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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