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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 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.

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. 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.

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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