FDA 510(k)

Optima Coil System (OptiBlock Line Extension)

N.º K: K242582 · 2024-09-27

Fecha de decisión2024-09-27

Código de productoHCG

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Optima Coil System (OptiBlock Line Extension) is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K242582. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Optima Coil System (OptiBlock Line Extension)?

Optima Coil System (OptiBlock Line Extension) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Balt USA, LLC. The 510(k) number is K242582.

When did Optima Coil System (OptiBlock Line Extension) receive FDA 510(k) clearance?

Optima Coil System (OptiBlock Line Extension) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K242582.

Who is the listed applicant for Optima Coil System (OptiBlock Line Extension)?

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

What is the FDA product code for Optima Coil System (OptiBlock Line Extension)?

The FDA product code for Optima Coil System (OptiBlock Line Extension) is HCG.

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Otros registros que enlistan a Balt USA, LLC como solicitante

K260199SLIM Microcatheter K254223Next Generation 088 Catheter K254221Optima Coil System (OptiOne Coil System)K252569Carrier XL Delivery Catheter K252700Optima Coil System (Optima Packing Coil System)K243948Raptor Aspiration Catheter; Balt Aspiration Tubing Set

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Fuente oficial

Ver en la base de datos de la FDA →

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