FDA 510(k)

Turbo-Elite Laser Atherectomy Catheter

Número K: K250385 · 2025-03-13

Data da decisão2025-03-13

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Turbo-Elite Laser Atherectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250385. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Turbo-Elite Laser Atherectomy Catheter?

Turbo-Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Spectranetics. The 510(k) number is K250385.

When did Turbo-Elite Laser Atherectomy Catheter receive FDA 510(k) clearance?

Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250385.

Who is the listed applicant for Turbo-Elite Laser Atherectomy Catheter?

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

What is the FDA product code for Turbo-Elite Laser Atherectomy Catheter?

The FDA product code for Turbo-Elite Laser Atherectomy Catheter is MCW.

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Dispositivos Relacionados (Código: MCW)

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