FDA 510(k)

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

N.º K: K242254 · 2025-04-21

SolicitanteDk Medical Technology Co., Ltd.

Fecha de decisión2025-04-21

Código de productoPNO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K242254. 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 D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Dk Medical Technology Co., Ltd.. The 510(k) number is K242254.

When did D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter receive FDA 510(k) clearance?

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-04-21, under 510(k) number K242254.

Who is the listed applicant for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

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

What is the FDA product code for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

The FDA product code for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is PNO.

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Otros registros que enlistan a Dk Medical Technology Co., Ltd. como solicitante

K232207D·Kutting™ PTA Scoring Balloon Dilatation Catheter K214009D·Kaptain PTA High Pressure Balloon Dilatation Catheter

Dispositivos relacionados (Código: PNO)

K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Catheter de Dilatación Balón PTA NSE ApertaGoodman Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC K232013Catheter de Dilatación Balón PTA NSE Aperta (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., Ltd.

Fuente oficial

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