FDA 510(k)

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

N.º K: K243184 · 2025-06-25

SolicitanteStrait Access Technologies Holdings

Fecha de decisión2025-06-25

Código de productoDQY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SAT CenterFlow Molding Balloon Catheter (IN20-00313) is the device name listed in this FDA 510(k) record. The listed applicant is Strait Access Technologies Holdings. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K243184. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

SAT CenterFlow Molding Balloon Catheter (IN20-00313) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Strait Access Technologies Holdings. The 510(k) number is K243184.

When did SAT CenterFlow Molding Balloon Catheter (IN20-00313) receive FDA 510(k) clearance?

SAT CenterFlow Molding Balloon Catheter (IN20-00313) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K243184.

Who is the listed applicant for SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

The FDA 510(k) record lists Strait Access Technologies Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

The FDA product code for SAT CenterFlow Molding Balloon Catheter (IN20-00313) is DQY.

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Fuente oficial

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