FDA 510(k)

PreludeSYNC™ Radial Compression Device

N.º K: K262086 · 2026-07-22

Fecha de decisión2026-07-22

Código de productoDXC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PreludeSYNC™ Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262086. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PreludeSYNC™ Radial Compression Device?

PreludeSYNC™ Radial Compression Device is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K262086.

When did PreludeSYNC™ Radial Compression Device receive FDA 510(k) clearance?

PreludeSYNC™ Radial Compression Device received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262086.

Who is the listed applicant for PreludeSYNC™ Radial Compression Device?

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

What is the FDA product code for PreludeSYNC™ Radial Compression Device?

The FDA product code for PreludeSYNC™ Radial Compression Device is DXC.

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Fuente oficial

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