FDA 510(k)

SmartClip Delivery Catheter (ADR-1715)

Número K: K260565 · 2026-05-14

Data da decisão2026-05-14

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartClip Delivery Catheter (ADR-1715) is the device name listed in this FDA 510(k) record. The listed applicant is Elucent Medical. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260565. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartClip Delivery Catheter (ADR-1715)?

SmartClip Delivery Catheter (ADR-1715) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Elucent Medical. The 510(k) number is K260565.

When did SmartClip Delivery Catheter (ADR-1715) receive FDA 510(k) clearance?

SmartClip Delivery Catheter (ADR-1715) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260565.

Who is the listed applicant for SmartClip Delivery Catheter (ADR-1715)?

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

What is the FDA product code for SmartClip Delivery Catheter (ADR-1715)?

The FDA product code for SmartClip Delivery Catheter (ADR-1715) is EOQ.

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Fonte oficial

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