FDA 510(k)

JADE SCORE PTA Scoring Balloon Dilatation Catheter

N.º K: K261778 · 2026-09-16

SolicitanteOrbusNeich Medical (Shenzhen) Co., Ltd.

Fecha de decisión2026-09-16

Código de productoPNO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

JADE SCORE PTA Scoring Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261778. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JADE SCORE PTA Scoring Balloon Dilatation Catheter?

JADE SCORE PTA Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K261778.

When did JADE SCORE PTA Scoring Balloon Dilatation Catheter receive FDA 510(k) clearance?

JADE SCORE PTA Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261778.

Who is the listed applicant for JADE SCORE PTA Scoring Balloon Dilatation Catheter?

The FDA 510(k) record lists OrbusNeich Medical (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JADE SCORE PTA Scoring Balloon Dilatation Catheter?

El código de producto de la FDA para el Catéter de Dilatación Balón de Escaneo PTA JADE SCORE es PNO.

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Otros registros que enlistan a OrbusNeich Medical (Shenzhen) Co., Ltd. como solicitante

K253361Teleport Glide Microcatheter K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)K233499Sapphire NC ULTRA Coronary Dilatation Catheter K233505Sapphire ULTRA Coronary Dilatation Catheter K241025JADE PLUS PTA Balloon Dilatation Catheter K231608Teleport XT Microcatheter

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Dispositivos relacionados (Código: PNO)

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Fuente oficial

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