FDA 510(k)

Santreva™-ATK Endovascular Revasculariztion Catheter

Número K: K252315 · 2025-09-22

Data da decisão2025-09-22

Código do produtoPDU

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Santreva™-ATK Endovascular Revasculariztion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is AngioSafe, Inc.. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K252315. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Santreva™-ATK Endovascular Revasculariztion Catheter?

Santreva™-ATK Endovascular Revasculariztion Catheter is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is AngioSafe, Inc.. The 510(k) number is K252315.

When did Santreva™-ATK Endovascular Revasculariztion Catheter receive FDA 510(k) clearance?

Santreva™-ATK Endovascular Revasculariztion Catheter received FDA 510(k) clearance on 2025-09-22, under 510(k) number K252315.

Who is the listed applicant for Santreva™-ATK Endovascular Revasculariztion Catheter?

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

What is the FDA product code for Santreva™-ATK Endovascular Revasculariztion Catheter?

The FDA product code for Santreva™-ATK Endovascular Revasculariztion Catheter is PDU.

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Fonte oficial

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