FDA 510(k)

AMPLATZER TorqVue 45x45 Delivery Sheath

Número K: K163000 · 2016-12-23

RequerenteAga Medical COrporation (Wholly Owned by St. Jude Medical CO

Data da decisão2016-12-23

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AMPLATZER TorqVue 45x45 Delivery Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K163000. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AMPLATZER TorqVue 45x45 Delivery Sheath?

AMPLATZER TorqVue 45x45 Delivery Sheath is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The 510(k) number is K163000.

When did AMPLATZER TorqVue 45x45 Delivery Sheath receive FDA 510(k) clearance?

AMPLATZER TorqVue 45x45 Delivery Sheath received FDA 510(k) clearance on 2016-12-23, under 510(k) number K163000.

Who is the listed applicant for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA 510(k) record lists Aga Medical COrporation (Wholly Owned by St. Jude Medical CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath is DQY.

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Fonte oficial

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