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FDA 510(k)

Frova Intubating Introducer

Número K: K161813 · 2017-05-19

RequerenteWilliam Cook Europe Aps
Data da decisão2017-05-19
Código do produtoBTR
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Frova Intubating Introducer is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K161813. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Frova Intubating Introducer?

Frova Intubating Introducer is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is William Cook Europe Aps. The 510(k) number is K161813.

When did Frova Intubating Introducer receive FDA 510(k) clearance?

Frova Intubating Introducer received FDA 510(k) clearance on 2017-05-19, under 510(k) number K161813.

Who is the listed applicant for Frova Intubating Introducer?

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

What is the FDA product code for Frova Intubating Introducer?

The FDA product code for Frova Intubating Introducer is BTR.

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Outros registros que listam William Cook Europe Aps como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K251596Lunderquist Extra Stiff Wire GuideK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterK220137Lunderquist Extra Stiff Wire GuideK211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

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Dispositivos Relacionados (Código: BTR)

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Fonte oficial

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