FDA 510(k)

TRACOE silcosoft Tracheostomy Tube

Número K: K172720 · 2018-04-27

Data da decisão2018-04-27

Código do produtoJOH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRACOE silcosoft Tracheostomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172720. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TRACOE silcosoft Tracheostomy Tube?

TRACOE silcosoft Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K172720.

When did TRACOE silcosoft Tracheostomy Tube receive FDA 510(k) clearance?

TRACOE silcosoft Tracheostomy Tube received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172720.

Who is the listed applicant for TRACOE silcosoft Tracheostomy Tube?

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

What is the FDA product code for TRACOE silcosoft Tracheostomy Tube?

The FDA product code for TRACOE silcosoft Tracheostomy Tube is JOH.

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Outros registros que listam Tracoe Medical GmbH como candidato(a)

K203362TRACOE vario K152778TRACOE Cuff Pressure Monitor K152865TRACOE smart Cuff Manager

Dispositivos Relacionados (Código: JOH)

K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTCovidien, LLC K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbH K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetCook Incorporated K182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien

Fonte oficial

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