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FDA 510(k)

VANES Delivery System (VDS)

K-Number: K260459 · 2026-04-06

ApplicantZoll Respicardia, Inc.
Decision Date2026-04-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Zoll Respicardia, Inc.. The 510(k) number is K260459.

When was VANES Delivery System (VDS) approved by the FDA?

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

What company makes VANES Delivery System (VDS)?

VANES Delivery System (VDS) is manufactured by Zoll Respicardia, Inc..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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