FDA 510(k)

Bioptimal Bipolar Pacing Catheter

N.º K: K242863 · 2025-06-15

SolicitanteBioptimal International Pte. , Ltd.

Fecha de decisión2025-06-15

Código de productoLDF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bioptimal Bipolar Pacing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bioptimal International Pte. , Ltd.. It received FDA 510(k) clearance on 2025-06-15 under 510(k) number K242863. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bioptimal Bipolar Pacing Catheter?

Bioptimal Bipolar Pacing Catheter is a medical device that received FDA 510(k) clearance on 2025-06-15. The listed applicant is Bioptimal International Pte. , Ltd.. The 510(k) number is K242863.

When did Bioptimal Bipolar Pacing Catheter receive FDA 510(k) clearance?

Bioptimal Bipolar Pacing Catheter received FDA 510(k) clearance on 2025-06-15, under 510(k) number K242863.

Who is the listed applicant for Bioptimal Bipolar Pacing Catheter?

The FDA 510(k) record lists Bioptimal International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioptimal Bipolar Pacing Catheter?

The FDA product code for Bioptimal Bipolar Pacing Catheter is LDF.

Ensayos clínicos relacionados

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Otros registros que enlistan a Bioptimal International Pte. , Ltd. como solicitante

K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

Dispositivos relacionados (Código: LDF)

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Fuente oficial

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