FDA 510(k)

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

N.º K: K181529 · 2018-12-06

Fecha de decisión2018-12-06

Código de productoLIT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, LLC. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K181529. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Contego Medical, LLC. The 510(k) number is K181529.

When did Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection receive FDA 510(k) clearance?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection received FDA 510(k) clearance on 2018-12-06, under 510(k) number K181529.

Who is the listed applicant for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

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

What is the FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

The FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is LIT.

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Otros registros que enlistan a Contego Medical, LLC como solicitante

K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

Dispositivos relacionados (Código: LIT)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.