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FDA 510(k)

VANES Delivery System (VDS)

Número K: K260459 · 2026-04-06

RequerenteZoll Respicardia, Inc.
Data da decisão2026-04-06
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

VANES Delivery System (VDS) is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Respicardia, Inc.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K260459. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VANES Delivery System (VDS)?

VANES Delivery System (VDS) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Zoll Respicardia, Inc.. The 510(k) number is K260459.

When did VANES Delivery System (VDS) receive FDA 510(k) clearance?

VANES Delivery System (VDS) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K260459.

Who is the listed applicant for VANES Delivery System (VDS)?

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

What is the FDA product code for VANES Delivery System (VDS)?

The FDA product code for VANES Delivery System (VDS) is DYB.

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Fonte oficial

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